This means that VK2809 can generate truly selective activation in the liver, making the issue of targeting bias a nonissue. Subjects were randomized to receive once-daily oral VK2809 doses of 0. ExhibitEX-99. The company recently received additional data from the low-dose 5 mg cohort in the Phase 2 trial of VK2809 trial in NAFLD and hypercholesterolemia. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. VK2809: Phase 2b (VOYAGE) Enrollment in ex-US sites to open later this year: The NASH drug development landscape is fraught with many failures. In a Phase 1 clinical trial of 76 adult male humans in which the dose size was varied, a dose-dependent increase in lean body mass was observed with no significant adverse events over 21 days. 12, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. Viking Therapeutics Inc. * Viking Therapeutics presents new clinical data on VK2809 in subjects with elevated cholesterol * Treatment with VK2809 was shown to be safe and well-tolerated at all doses studied in trial. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of new results from the company's 12-week Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with. VK2809 is being evaluated for the treatment of non-alcoholic fatty liver disease (NAFLD) and high cholesterol. Viking Therapeutics Reports Fourth Quarter and Year-End 2019 Financial Results and Provides Corporate Update Conference call scheduled for 4:30 p. Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The. Viking is conducting a randomized, double-blind, placebo-controlled, parallel group Phase-2 study to determine VK2809's efficacy, safety and tolerability in patients with elevated LDL-C (low density lipoprotein - shows the level of cholesterol in blood) and non-alcoholic fatty liver disease. G&H What was the design of the phase 2 study on MGL-3196 for the treatment of NASH? ZY Results from the phase 2 trial were presented at last year's American Association for the Study of Liver Diseases meeting. Loomba R, Neutel J, Bernard D, Severance R, Mohseni R, Dao M, Saini S, Margaritescu C, Homer K, Tran B, Mancini M, Masamune H, Lian B 2018 VK2809, a novel liver-directed thyroid receptor beta agonist, significantly reduces liver fat in patients with nonalcoholic fatty liver disease: a phase 2 randomized placebo-controlled trial [abstract]. VK2809 belongs to a family of novel prodrugs, which are cleaved in vivo to release potent thyromimetics. Viking Therapeutics Announces VK2809 Phase 2 Study Results Selected for Oral Late-Breaker Presentation at The Liver Meeting® 2018 New Data from Phase 2 Flu Challenge Study Demonstrates Vaxart’s Oral H1 Flu Vaccine Generated Protective Mucosal Immunity ( Press ). (GALT) Belapectin: Due to enter Phase 3 in Q2. Conclusion While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given the uncertainty in executing a Phase 2/3 trial and the fact that essentially everyone Viking sought council from regarding the matter advised. The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with GSD Ia. Phase 2 successes for Madrigal Pharmaceuticals' hormone receptor agonist MGL-3196 and Viking Therapeutics' thyroid beta agonist VK2809 led to big stock surges for both biotechs last year — though the share price for each has since trickled back down. Loomba R, Neutel J, Mohseni R, et al. (NASDAQ: VKTX) and its Phase 2 trial of VK2809 trial in Non-alcoholic fatty liver disease (NAFLD) and Intercept Pharmaceuticals, Inc. After reporting encouraging phase 2 drug trails for the drug VK2809 in treating patients with non-alcoholic fatty acid liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C),Viking Therapeutics is more than 50% below its highs set last year. VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor that is entering Phase II development for the treatment of patients with hypercholesterolemia and fatty liver disease. 7bn in US sales alone. Strong data raise hopes for Viking's VK2809 in NAFLD, NASH. The randomized, double. This phase II trial included 125 people with NASH confirmed by liver biopsy. The trial's primary endpoint assessed the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. If you are looking for a stock blog about hot stocks that are rising, you came to the right place. As a consequence, the other projects were terminated as well. The planned Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled study to assess the efficacy, tolerability and safety of VK2809 in around 100 individuals with high LDL-C levels and fatty liver disease. Jazz Pharmaceuticals saw a boost after announcing positive top-line results from the Phase 3 study evaluating the safety and efficacy of JZP-258 for the treatment of cataplexy and excessive daytime sleepiness (EDS) in adult patients with narcolepsy. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. After 52 weeks of treatment a second biopsy is performed. broker reports. 34, approximately 2,746,254 shares were traded during trading. Viking Therapeutics, Inc. BTIG Research’s price target would suggest a potential upside of 65. The tensions between the U. Viking Therapeutics Inc. Each of these compounds was able to reduce low-density lipoprotein cholesterol, but a phase 3 trial with eprotirome was interrupted because of a significant increase in liver enzymes and the contemporary report of cartilage side effects in animals. The Phase 2 trial was a randomized, double blind, placebo. Phase 2 trial was basis for phase 3 (stage 2,3 fibrosis; 36 weeks) Phase 3 Trial § NASH with fibrosis stage 1a, 1b, 2, 3 with NAS ≥4 and score of at least 1 in all 3 components § N=2000 § Placebo vs. MRI-PDFF (magnetic resonance imaging estimation of proton density fat fraction) indicated at least 10% liver fat. 7bn in US sales alone. placebo after 12 weeks. Wall Street is experiencing a great déjà vu. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. The Phase 2 trial was a randomized, double blind, placebo. announced its orally available VK2809 was dosed in its first patient as part of a phase 2 clinical trial. * Viking Therapeutics presents new clinical data on VK2809 in subjects with elevated cholesterol * Treatment with VK2809 was shown to be safe and well-tolerated at all doses studied in trial. The conference runs from 10-14 April, 2019. 12, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. Results from phase II trials. 9% for those who received the placebo. Other equities analysts have also issued research reports about the company. Continue if you are OK with this. Ardelyx, T3MPO-2 Phase 3 Study. Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via. In this multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2a study, we recruited adults (aged 21-75 years) with a body-mass index of at least 25 kg/m 2, biopsy-confirmed non-alcoholic steatohepatitis (fibrosis stage 1-3), and a hepatic fat fraction of at least 10% when assessed by magnetic resonance imaging-proton density fat fraction. VK2809 is a promising thyroid hormone receptor β-selective agonist in early phase clinical trial for metabolic disorders. Patients were randomized to receive placebo (n = 14), 10 mg VK2809 dosed every other day (QOD, n = 15), or 10 mg VK2809 dosed daily (QD, n = 16) for 12 weeks followed by a four-week off-drug phase. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. The randomized, double. (NASDAQ:VKTX) is currently conducting the Phase 2b VOYAGE trial of VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH). Phase 3 (AURORA) Topline data expected in Q4, 2020: 3: Galmed Pharma Ltd. 7 Thyroid hormone receptor. Results from the ongoing Phase 2 clinical trial of VK2809 in hypercholesterolemia and fatty liver disease are expected in the fourth quarter of 2017, and if those results are similar to what was. Obesity, type 2 diabetes (T2D), hyperlipidemia, and hypertension are highly prevalent in individuals with NAFLD and, therefore, NAFLD risk factors are almost identical to the constituents of the metabolic syndrome 2, 3. I suspect that the probability is somewhat better for VK2809 since it has already delivered positive results from the phase 2 study in NAFLD and hypercholesterolemia. The company is enrolling patients with elevated cholesterol, fatty liver disease, and at least three risk factors for metabolic syndrome, which is considered a major driver for the. Madrigal Pharmaceuticals had released important biopsy/histological data from a 36-week assessment of patients dosed with MGL-3196 as part of a Phase II trial for the compound; and Viking shareholders were happy to just go along for the ride, piggy-backing off of the results. 26 and a 1-year high of $9. Viking Therapeutics expects to meet with the FDA to discuss the framework for further studies. The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with GSD Ia. If VK2809 shows statistical significance in liver fat reduction, it could cement its position as one of the most promising NASH drug candidates in the industry ahead of a phase 3 study. Initiation of Phase 2b NASH trial planned in 2H19. Viking expects to report phase 2 results for VK2809 sometime in the second half of 2018. Research analysts at Maxim Group started coverage on shares of Viking Therapeutics (NASDAQ:VKTX) in a research report issued on Saturday, TipRanks reports. VK2809 is a promising thyroid hormone receptor β-selective agonist in early phase clinical trial for metabolic disorders. Visit http. VK2809 is being evaluated for the treatment of non-alcoholic fatty liver disease (NAFLD) and high cholesterol. The Phase 3 MAESTRO-NASH trial is expected to enroll 2000 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. During the development of this therapy an off-target effect of bradycardia occurring up to 6 hours after the dose was identified. The conference runs from 10-14 April, 2019. Last year, Gilead's Selonsertib in phase III trial. VK2809: Phase 2b (VOYAGE) Enrollment in ex-US sites to open later this year: The NASH drug development landscape is fraught with many failures. Patients received 10 mg VK2809 every other day or a 10-mg dose daily and were also randomized to receive a placebo for 12 weeks followed by a four week. The trial's primary endpoint assessed the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. In its most recent clinical trials, VK2809 completed a Phase 2 trial with successful results at a residential addiction treatment facility. 10 Figure 1: Datamonitor Healthcare’s drug assessment summary of VK2809 for NASH 11 Figure 2: Datamonitor Healthcare’s drug assessment summary of VK2809 for NASH. VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor that is entering Phase II development for the treatment of patients with hypercholesterolemia and fatty liver disease. When free fatty acids (FFAs) are either oversupplied or their disposal is damaged, they may be used as substrates for the production of lipotoxic species (e. If successful though, I do not see why VKTX could not seek accelerated approval around the 18-month mark, if they make it to phase 3. Viking Therapeutics, Inc. OCA, a potent farnesoid X receptor agonist, administered at a 25‐mg/day dose improved steatohepatitis and fibrosis over a 72‐week period in a large, multicenter, phase 2b clinical trial. Its lead drug candidate is VK2809, an orally available tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta, which is in Phase II clinical trials to treat patients with non-alcoholic fatty liver disease and elevated low-density lipoprotein cholesterol. The Phase 3 MAESTRO-NASH trial is expected to enroll 2000 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. " The study was designed to evaluate VK2809 dosed orally (10 mg/kg/day) for eight weeks in a mouse model of diet-induced NASH. VK2809-105: A Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of VK2809 dosed in an every-other-day (QOD) regimen. If that profile translates into a phase 3 win they think the drug could make $1. Study Title. Preclin Phase 1 Phase 2 Phase 3 VK2809 (TRb agonist) NASH Phase 2b VOYAGE trial ongoing VK0214 (TRb agonist) X-ALD IND planned, 2020 Other Programs Preclin Phase 1 Phase 2 Phase 3 VK5211 (SARM) Hip fracture, muscle wasting Phase 2 completed VK0612 (FBPase inhibitor) Type 2 Diabetes Phase 2a completed VK1430 (DGAT-1 inhibitor. Phase II trials on GC-1 and MB07344 are yet to be performed. The company's lead drug candidate also includes VK5211, an. LIST OF TABLES 6 Table 1: VK2809 drug profile 8 Table 2: Late-phase trials of VK2809 for NASH 9 Table 3: VK2809 for NASH - SWOT analysis. These data confirmed previously reported results. The company's lead program, VK2809 , is an oral thyroid hormone receptor agonist that has a high selectivity from liver tissue as well as the beta receptor subtype. The randomized, double. VKTX ended 3Q16 with cash of ) ~$14. VK2809 was shown to be safe and well-tolerated in the. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. Its lead drug elafibranor should produce Phase 3 results later this year. (MDGL), which is currently studying resmetirom in a Phase 3 trial for the treatment of NASH, we view VK2809 as a potential ‘best-in-class’ treatment for NASH based on its efficacy, potency, and safety. 34, approximately 2,746,254 shares were traded during trading. This could be a good time to add a profit-friendly play, a clinical-stage upstart, and a make-or-break biotech to your portfolio. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. Viking Therapeutics Inc. Je commencerai par commenter l’état d’avancement de notre essai de Phase 2B Voyage dans le contexte de la pandémie de coronavirus. Much focus will be on stocks such as Viking Therapeutics, Inc. The company had a trading volume of 1,573,312 shares, compared to its average volume of 1,397,112. 3% of NASH subjects treated with VK2809 (combined two doses) had a ≥ 30% reduction in liver fat at 12 weeks. The move translates. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. Phase 2b VOYAGE study underway evaluating VK2809 in biopsy-confirmed NASH. VK2809 is being evaluated for the treatment of non-alcoholic fatty liver disease (NAFLD) and high cholesterol. is the leading provider of real-time or delayed intraday stock and commodities charts and quotes. Treatment with asfotase alfa 0. SanaCurrents predicted a high likelihood of success for the phase II study, and identified Viking Therapeutics as an underrated and undervalued player in the $30 billion addressable NASH market. Phase 2 clinical trial of VK2809 in NAFLD and hypercholesterolemia nearing completion of enrollment. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of new results from the company's 12-week Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with. OCA, a potent farnesoid X receptor agonist, administered at a 25‐mg/day dose improved steatohepatitis and fibrosis over a 72‐week period in a large, multicenter, phase 2b clinical trial. MedChemExpress provides 15,000+ selective Inhibitors and Agonists with high purity and quality. The data, already known by the market, comes from the recently completed Phase 2 clinical trial, but the meeting will be important to gauge the temperature of institutions and big pharma. 2 Three doses (5 mg daily [QD], 10 mg QD, 10 mg every other day [QOD]) were compared with placebo. Loomba R, Neutel J, Bernard D, et al. I also talk about the DBVT BLA resubmission and a hot hot Q319 trading idea on CBIO. 12-04-2019. Viking also announced plans to initiate a Phase 2b study of VK2809 in biopsy-confirmed NASH in the second half of 2019. Preclin Phase 1 Phase 2 Phase 3 VK2809 (TRb agonist) NASH Phase 2b VOYAGE trial ongoing VK0214 (TRb agonist) X-ALD IND planned, 2020 Other Programs Preclin Phase 1 Phase 2 Phase 3 VK5211 (SARM) Hip fracture, muscle wasting Phase 2 completed VK0612 (FBPase inhibitor) Type 2 Diabetes Phase 2a completed VK1430 (DGAT-1 inhibitor. March 16, 2019 7:10 am. Should VK2809 prove as successful in phase 3 studies as it was in phase 2, Viking will likely have a megablockbuster on its hands. (NASDAQ:VKTX) is currently conducting the Phase 2b VOYAGE trial of VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH). This could be a good time to add a profit-friendly play, a clinical-stage upstart, and a make-or-break biotech to your portfolio. The treatment is being assessed as an option for patients. The difference this time? These…. This means that VK2809 can generate truly selective activation in the liver, making the issue of targeting bias a nonissue. VK2809: Viking Therapeutics announced initiation of enrollments for NASH patients with varied stages of fibrosis for a Phase 2b efficacy and tolerability study. Another drug -- VK5211 -- looks pretty good, too. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced its financial results for the fourth quarter and year ended December 31, 2018, and provided an update on its clinical pipeline and other corporate developments. Patients in the phase 2 study were randomized to receive placebo or a 10-mg dose of VK2809 either every day or every other day. (Nasdaq:ICPT) with data from its Phase 3 trial for non-alcoholic steatohepatitis (NASH). Source Reference: Loomba R, et al “VK2809, a Novel Liver-Directed Thyroid Receptor Beta Agonist, Significantly Reduces Liver Fat in Patients with Non-Alcoholic Fatty Liver Disease: A Phase 2. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. 3% during trading on Monday. HC Wainwright cut their price objective on shares of […]. For VK0214, the theory behind its potential use in X-ALD has been validated through the increased expression of. This phase II trial included 125 people with NASH confirmed by liver biopsy. Its two molecules are VK2809 and VK0214. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given. Viking also announced plans to initiate a Phase 2b study of VK2809 in biopsy-confirmed NASH in the second half of 2019. 's (CBAY) phase 2b study of. april 11 (reuters) - viking therapeutics inc ::viking therapeutics presents new data from phase 2 study of vk2809 in patients with non-alcoholic fatty liver disease (nafld) and elevated. plus positive data last month with results from its ongoing phase 1/2 study of DTX301 gene therapy for. About the Phase 2 NASH Study The randomized, double-blind, placebo-controlled, multi-center Phase 2 study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included approximately 25 clinical sites in the United States. Viking Therapeutics Announces VK2809 Phase 2 Study Results Selected for Oral Late-Breaker Presentation at The Liver Meeting® 2018 New Data from Phase 2 Flu Challenge Study Demonstrates Vaxart’s Oral H1 Flu Vaccine Generated Protective Mucosal Immunity ( Press ). Should VK2809 prove as successful in phase 3 studies as it was in phase 2, Viking will likely have a megablockbuster on its hands. We have been proactive in implementing steps to mitigate the potential impact of the coronavirus pandemic, and are closely monitoring this evolving challenge. 사진: 유럽간학회(EASL) 홈페이지 [메디게이트뉴스 박도영 기자] 세계 인구의 25% 이상이 비알코올성지방간(NAFLD)을 가지고 있고, 이 환자의 59%는 간경화와 간부전, 간세포암으로 진행될 수 있는 비알코올성지방간염(NASH)으로 진행되는 것으로 추정되고 있다. Viking Therapeutics, Inc. This followed positive results for lowering of liver fat in NAFLD patients with good safety in a Phase 2 trial. The Company has completed enrollment in the Phase 2 trial of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated LDL cholesterol, and looks forward to reporting the results from this study in the fall. 7 Thyroid hormone receptor. 3 Investment Highlights Focused on best-in-class drugs for metabolic and endocrine diseases -Two Phase 2 programs supported by positive clinical data Metabolic Disease Program: VK2809 for NASH -Novel, selective thyroid receptor-b(TRb) agonist -Phase 2 results demonstrate significant reduction in liver fat content, lipids. The randomized, double. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. We will be very interested to review the data from the Phase 2 study of VK2809 in patients with hepatic steatosis/NAFLD, which we anticipate in the first half of 2018. The trial successfully achieved its primary endpoint, with patients receiving VK2809. Madrigal is already looking to advance MGL-3196 to a pivotal phase 3 clinical trial. If you are looking for a stock blog about hot stocks that are rising, you came to the right place. Viking Therapeutics currently intends to use the proceeds from the offering for continued development of its VK5211, VK2809 and VK0214 programs and for general research and development, working capital and. 131 Table 34: Late-phase trials of Ocaliva for NASH 133 Table 35: Ocaliva for NASH – SWOT analysis 141 Table 36: VK2809 drug profile 143 Table 37: Late-phase trials of VK2809 for NASH 144 Table 38: VK2809 for NASH – SWOT analysis 149 Table 39: Cenicriviroc drug profile 151 Table 40: Late-phase trials of cenicriviroc for NASH. Based on historical data, the odds of a liver disease drug in phase 2 clinical testing going on to win FDA approval is only 1-in-4. Wall Street is experiencing some major déjà vu. Clinical Impact of New NAFLD/NASH Data From San Francisco 2018 1. (VKTX) has completed enrollment in its ongoing Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease 3. In a little over three weeks, Viking Therapeutics Inc (Nasdaq: VKTX) will present its Phase 2 study results for its potential blockbuster drug VK2809. While four companies — Intercept Pharmaceuticals, Gilead Sciences, Genfit and Allergan — have advanced experimental NASH treatments into Phase 3 testing, the field remains open. 2019-10-30 : PharmaNest Announces New Adult and Pediatric NASH Data to Be Presented at the AASLD - Liver Meeting® 2019. The trial's primary endpoint assessed the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. Preclin Phase 1 Phase 2 Phase 3 VK2809 (TRb agonist) NASH Phase 2b VOYAGE trial ongoing VK0214 (TRb agonist) X-ALD IND planned, 2020 Other Programs Preclin Phase 1 Phase 2 Phase 3 VK5211 (SARM) Hip fracture, muscle wasting Phase 2 completed VK0612 (FBPase inhibitor) Type 2 Diabetes Phase 2a completed VK1430 (DGAT-1 inhibitor. VK 2809 (formerly MB 07811) is a second generation, orally available small molecule, beta thyroid hormone receptor (TRβ) agonist, being developed by Viking VK 2809 - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript. The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with GSD Ia. Thyroid hormones have important effects on cellular development, growth, and metabolism and are necessary for the healthy function of almost all tissues []. Another drug -- VK5211 -- looks pretty good, too. 50 and low of $3. ExhibitEX-99. The data in particular came from the 12-week Phase 2 study of VK2809. It is developing VK0214 for the treatment of X-linked adrenoleukodystrophy (X-ALD). " The study was designed to evaluate VK2809 dosed orally (10 mg/kg/day) for eight weeks in a mouse model of diet-induced NASH. The company is enrolling patients with elevated cholesterol, fatty liver disease, and at least three risk factors for metabolic syndrome, which is considered a major driver for the. Wall Street is experiencing some major déjà vu. As a consequence, the other projects were terminated as well. Please read our privacy policy for more details. 5 Go to Top References: 1. And, until VK2809 proves itself in patients with NASH fibrosis there is an overhanging risk of its own. This could be a good time to add a profit-friendly play, a clinical-stage upstart, and a make-or-break biotech to your portfolio. After 12 weeks of treatment, patients receiving VK2809 had. In phase 2 testing, VK2809 was shown to significantly reduce fat in the liver - another key pathology in NASH - and have good tolerability. Submission. VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promise in this patient population. [Epub ahead of print] Thyroid hormone analogues: an update. There are two main types of thyroid hormones; L-triiodothyronine (T 3) and L-thyroxine (T 4). Highlights from the Quarter, and Subsequent to December 31, 2018: "The past year has been a transformative period for Viking, and we are excited to continue this momentum in 2019," stated Brian Lian, Ph. Loomba R, Neutel J, Bernard D, et al. 20net loss per share. Phase 2 additional NAFLD data to be presented at EASL on April 11, 2019. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given. If successful though, I do not see why VKTX could not seek accelerated approval around the 18-month mark, if they make it to phase 3. Phase 2b VOYAGE study underway evaluating VK2809 in biopsy-confirmed NASH. In June, Viking Therapeutics. 7bn in US sales alone. NASH drugs come into focus as field awaits late-stage data Kendall Davis / BioPharma Dive when three of the four NASH front-runners are expected to read out late-stage data. NASH NEWS —Genfit (NASDAQ: GNFT), a French company with one of the most advanced experimental treatments for the fatty liver disease nonalcoholic steatohepatitis, raised $135 million in a U. TipRanks Blog May 4, 2020. "Overall, we view VK2809's. Phase 2 Trials ongoing in head/neck and ovarian cancer Phase 2 ovarian data 1H2016 Lilly Prexasertib (Oncology) Phase 2 Multiple trials ongoing in various cancers Data readouts in 2016, 2017, and 2018 Merrimack MM-302 (Oncology) Phase 2/3 Robust activity in heavily pre-treated HER2+ metastatic breast cancer Filing in 2017, potential accelerated. Actual Study Start Date : Estimated Primary Completion Date : Estimated Study Completion Date :. SECOND wave candidates. About the Phase 2 NASH Study The randomized, double-blind, placebo-controlled, multi-center Phase 2 study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included approximately 25 clinical sites in the United States. Success by any could lead to the first approved therapy for the complex disease. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn't face much of a disruption. Each of these compounds was able to reduce low-density lipoprotein cholesterol, but a phase 3 trial with eprotirome was interrupted because of a significant increase in liver enzymes and the contemporary report of cartilage side effects in animals. The difference this time? These tariffs would serve as a punishment for China's role in the COVID-19. 12, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. com reports. Last year, Gilead's Selonsertib in phase III trial. * Expect to complete ongoing phase 2 trial of VK2809 inpatients with hypercholesterolemia and fatty liver disease in1H17Source text for Eikon: Further company coverage: Read the original article. Based upon the data that has been presented thus far by Viking and Madrigal Pharmaceuticals, Inc. In this multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2a study, we recruited adults (aged 21-75 years) with a body-mass index of at least 25 kg/m 2, biopsy-confirmed non-alcoholic steatohepatitis (fibrosis stage 1-3), and a hepatic fat fraction of at least 10% when assessed by magnetic resonance imaging-proton density fat fraction. The company is enrolling patients with elevated cholesterol, fatty liver disease, and at least three risk factors for metabolic syndrome, which is considered a major driver for the. In November 2019, we initiated the VOYAGE study, a Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis, or NASH. LIST OF TABLES 6 Table 1: VK2809 drug profile 8 Table 2: Late-phase trials of VK2809 for NASH 9 Table 3: VK2809 for NASH - SWOT analysis. htm Exhibit 99. VK2809: Viking Therapeutics announced initiation of enrollments for NASH patients with varied stages of fibrosis for a Phase 2b efficacy and tolerability study. Viking Therapeutics Presents New Data from Phase 2 Study of VK2809. VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis: Actual Study Start Date : November 15, 2019. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. Of note, metabolic inflammation is primarily mediated by innate immune signaling, which is increasingly. SanaCurrents predicted a high likelihood of success for the phase II study, and identified Viking Therapeutics as an underrated and undervalued player in the $30 billion addressable NASH market. An increase of 94% from the average daily volume of 1,417,566 shares. CENTAUR Study: cenicriviroc in NASH (phase 2b) Friedman SL, Hepatology 2018;67:1754-67, Ratziu , EASL 2018, Abs. Phase 2 clinical trial of VK2809 in NAFLD and hypercholesterolemia nearing completion of enrollment. The Phase 2 trial was a double-blind, randomized, placebo-controlled study designed to determine the efficiency, safety and tolerability of the candidate VK2809 in patients with NAFLD and LDL-C. The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in phase 2 development for. A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation. 3 "Strong Buy" Biotech Stocks Trading Under $10. (NASDAQ:VKTX) announced that the Phase 2b VOYAGE trial of VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) is underway. com reports. Currently, obeticholic acid (OCA; NCT02548351) and elafibranor (NCT02704403) are two compounds that are being tested in phase 3 registration trials. If successful though, I do not see why VKTX could not seek accelerated approval around the 18-month mark, if they make it to phase 3. Its lead drug candidate is VK2809, an orally available tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta, which is in Phase 2b clinical trials to treat. 12, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. Nonetheless, companies report positive clincial data all the time and don’t run in multiples. VK2809 is a promising thyroid hormone receptor β-selective agonist in early phase clinical trial for metabolic disorders. Viking Therapeutics Inc (NASDAQ:VKTX) has been through a rough patch that likely has many long-term shareholders living in the shadow of the regret of not selling some shares back in early September, when the stock launched up to nearly test $30/share in premarket trading (almost tripling in price in a matter of hours) following the company's announcement of positive top-line results from a. The Science Rucaparib or Rubraca® is a PARP inhibitor currently being investigated for use as an anti-cancer agent by Clovis Oncology. The Phase 3 MAESTRO-NASH trial is expected to enroll 2000 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. Viking Therapeutics (VKTX) Says Phase 2 Study of VK2809 in Patients with NAFLD and Elevated LDL-Cholesterol Achieved its Primary Endpoint 00 a. The data in particular came from the 12-week Phase 2 study of VK2809. 8 billion on R&D to advance partnered programs, including funding 17 Phase 3 trials and 44 Phase 2 trials. Viking Therapeutics, Inc. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. 4, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The. Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you. LIST OF TABLES 6 Table 1: VK2809 drug profile 8 Table 2: Late-phase trials of VK2809 for NASH 9 Table 3: VK2809 for NASH - SWOT analysis. The Company also announced the ongoing VK2809 Phase-2 fatty liver and hypercholesterolemia study enrollment and VK2809 proof-of-concept study in glycogen storage disease type-la planned offer for. In a little over three weeks, Viking Therapeutics Inc (Nasdaq: VKTX) will present its Phase 2 study results for its potential blockbuster drug VK2809. placebo after 12 weeks. Instead, the company is floating the idea of commencing a combined Phase 2/3 trial in order to assess the drug on a NASH approvable endpoint. On September 18, Viking Therapeutics issued a press release announcing positive results from the phase 2 trial evaluating VK2809 in NALFD (non-alcoholic fatty liver disease) patients with high LDL. More recently, two liver-directed THRB selective agonists, MGL-3196 and VK2809, have been developed [160, 161]. Patients were randomized to receive placebo (n = 14), 10 mg VK2809 dosed every other day (QOD, n = 15), or 10 mg VK2809 dosed daily (QD, n = 16) for 12 weeks followed by a four-week off-drug phase. VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor that is entering Phase II development for the treatment of patients with hypercholesterolemia and fatty liver disease. Similar to MGL-3196, in the placebo-controlled 12-week phase-2 trial, VK2809 significantly reduced hepatic fat assessed by imaging in NASH patients and a phase-2b study is planned. The company traded as high as $6. Read "A PHASE 1 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF THE LIVER-SELECTIVE TR-BETA AGONIST VK2809 (MB07811) IN HYPERCHOLESTEROLEMIC SUBJECTS, Journal of the American College of Cardiology" on DeepDyve, the largest online rental service for scholarly research with thousands of academic publications. In addition to the impressive efficacy observed, VK2809 has also demonstrated an encouraging safety and tolerability profile. And, until VK2809 proves itself in patients with NASH fibrosis there is an overhanging risk of its own. VK2809: Phase 2b (VOYAGE) Enrollment in ex-US sites to open later this year: The NASH drug development landscape is fraught with many failures. The phase II study on VK2809 met the primary endpoint by demonstrating statistically significant reductions in LDL-C or "bad cholesterol" levels by more than 20% in comparison to placebo. Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. In the Phase 2 study, no serious adverse events were reported among patients receiving VK2809 or placebo and the overall numbers of adverse events were relatively evenly distributed across treatment arms. "We see the only advantage retained by Madrigal at this point being time-to-Phase 3. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. The tensions between the U. Wall Street is experiencing some major déjà vu. Strong data raise hopes for Viking's VK2809 in NAFLD, NASH. 4, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. The prevalence of NAFLD is rapidly increasing worldwide and it is now the most common liver disorder in the Western world. co/wDQh020yLD. Metavant updated Ligand that they no longer plan to initiate a clinical proof-of-concept trial this year for RVT-1502 in Type 1 diabetes following requests from FDA for additional non-clinical studies. 1 2 vktx-ex991_6. Protectionist trade policies have really been whipsawing the market. GS-9674 and GS-0976 are currently in Phase 2 NASH studies. BTIG Research began coverage on shares of Viking Therapeutics (NASDAQ:VKTX) in a report issued on Friday, MarketBeat Ratings reports. 88% from the company’s current price. Much focus will be on stocks such as Viking Therapeutics, Inc. VK2809 for hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). The firm set a “buy” rating and a $14. 10 Figure 1: Datamonitor Healthcare's drug assessment summary of VK2809 for NASH 11 Figure 2: Datamonitor Healthcare's drug assessment summary of VK2809 for NASH. 21 on Wednesday. The randomized, double. The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with GSD Ia. Should VK2809 prove as successful in phase 3 studies as it was in phase 2, Viking will likely have a megablockbuster on its hands. William Blair reaffirmed a buy rating on shares […]. As a consequence, the other projects were terminated as well. "We were particularly pleased in 2018 to have presented positive Phase 2 data from our novel thyroid receptor beta agonist VK2809 in non. 00 price objective on the biotechnology company’s stock. Viking Therapeutics, Inc. Viking expects to report phase 2 results for VK2809 sometime in the second half of 2018. MedChemExpress provides 15,000+ selective Inhibitors and Agonists with high purity and quality. Phase 2 trial was basis for phase 3 (stage 2,3 fibrosis; 36 weeks) Phase 3 Trial § NASH with fibrosis stage 1a, 1b, 2, 3 with NAS ≥4 and score of at least 1 in all 3 components § N=2000 § Placebo vs. Viking Therapeutics Inc. We will be very interested to review the data from the Phase 2 study of VK2809 in patients with hepatic steatosis/NAFLD, which we anticipate in the first half of 2018. (MDGL), which is currently studying resmetirom in a Phase 3 trial for the treatment of NASH, we. VK2809 is currently in a Phase 2 study in patients with NSFLD and elevated LDL cholesterol, and data are expected in 2H18, which we see as a potentially significant driver for the shares. Clinical-stage biopharmaceutical company Viking Therapeutics, Inc. VK2809, a novel liver-directed thyroid receptor beta agonist, significantly reduces liver fat in patients with non-alcoholic fatty liver disease: a phase 2 randomized, placebo-controlled trial [abstract LB-4]. Robust Phase 2 Data for VK2809 in NAFLD! On September 18, 2018, Viking Therapeutics, Inc. (VKTX) has completed enrollment in its ongoing Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine. Viking Therapeutics doubles on Madrigal's positive phase 2 NASH results. During the development of this therapy an off-target effect of bradycardia occurring up to 6 hours after the dose was identified. The trial's primary endpoint assessed the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. Its lead drug candidate is VK2809, an orally available tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta, which is in Phase 2b clinical trials to treat. To meet regulatory requirements for phase 2/3 trials to evaluate efficacy and safety of the drug, heart rate (HR) needed to be monitored via ECG by a centralized lab for a minimum of 6 hours after the dose. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. (NASDAQ:AGEN) Agenus is an immunotherapy penny stock that has had a rough start to 2020, having lost almost 50% of its value year to date. Conference call scheduled for 4:30 p. I also talk about the DBVT BLA resubmission and a hot hot Q319 trading idea on CBIO. I suspect that the probability is somewhat better for VK2809 since it has already delivered positive results from the phase 2 study in NAFLD and hypercholesterolemia. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine. Viking Therapeutics Presents New Data from Phase 2 Study of VK2809. Other equities analysts have also issued research reports about the company. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn't face much of a disruption. In phase 2 trials, both of these medications have been shown to effectively reduce liver fat content and LDL cholesterol (NCT02927184 and NCT02912260). This means that VK2809 can generate truly selective activation in the liver, making the issue of targeting bias a nonissue. The following figures show that VK2809 (MB07811) was at least as effective in lowering plasma cholesterol as atorvastatin (Lipitor®) in all three species, and an additive effect exists with the combination of VK2809 and atorvastatin. Lipid metabolic disorder is the most direct etiology of NAFLD. Its lead drug candidate is VK2809, an orally available tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta, which is in Phase II clinical trials to treat patients with non-alcoholic fatty liver disease and elevated low-density lipoprotein cholesterol. The randomized, double. Another drug -- VK5211 -- looks pretty good, too. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given. (MDGL), which is currently studying resmetirom in a Phase 3 trial for the treatment of NASH, we view VK2809 as a potential ‘best-in-class’ treatment for NASH based on its efficacy, potency, and safety. The company recently received additional data from the low-dose 5 mg cohort in the Phase 2 trial of VK2809 trial in NAFLD and hypercholesterolemia. GS-9674 and GS-0976 are currently in Phase 2 NASH studies. Positive results for MGL-3196 should bode well for Viking's chances with VK2809. Phase 2 additional NAFLD data to be presented at EASL on April 11, 2019. Subjects were randomized to receive once-daily oral VK2809 doses of 0. Of note, metabolic inflammation is primarily mediated by innate immune signaling, which is increasingly. 46 on Tuesday after reporting that VK2809 met the primary and secondary endpoints in a Phase II trial to treat non-alcoholic fatty liver disease. 14% from the stock’s previous close. - Additional VK2809 Phase 2 Results Selected for Podium Presentation at EASL - IND Filing for VK0214 in X-ALD Expected in 2Q20 - Balance Sheet Remains Strong, Year-End Cash Approximately $275 Million. TipRanks Blog May 4, 2020. and China flared after President Trump threatened to impose new import tariffs. In a Phase 1 clinical trial of 76 adult male humans in which the dose size was varied, a dose-dependent increase in lean body mass was observed with no significant adverse events over 21 days. This breadth of activity highlights VK2809's differentiated mechanism of action and exciting potential therapeutic profile. 99 and its 200 day moving average price is $6. This phase II trial included 125 people with NASH confirmed by liver biopsy. According to a press release from American biotechnology company Intercept Pharmaceuticals, the company recently released additional data supporting its phase 3 clinical trial of obeticholic acid (OCA) in the treatment…. 7bn in US sales alone. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. 34 and last traded at $6. Price and Volume Movers. ceramides, diacylglycerols, and lysophosphatidyl choline species) that trigger inflammation and. Viking Therapeutics (VKTX) Presents New Data from Phase 2 Study of VK2809 in Patients with NAFLD and Elevated LDL-Cholesterol at EASL. 131 Table 34: Late-phase trials of Ocaliva for NASH 133 Table 35: Ocaliva for NASH – SWOT analysis 141 Table 36: VK2809 drug profile 143 Table 37: Late-phase trials of VK2809 for NASH 144 Table 38: VK2809 for NASH – SWOT analysis 149 Table 39: Cenicriviroc drug profile 151 Table 40: Late-phase trials of cenicriviroc for NASH. Patients in the phase 2 study were randomized to receive placebo or a 10-mg dose of VK2809 either every day or every other day. Our discussion with management which largely focused on VK2809’s safety profile re-affirmed our thesis and in terms of timing, it indicated it plans to file the IND with the GI division by the end of 3Q19 or in early 4Q19 setting up the Phase 2b start by year-end. The Phase 2 study was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL-C and. Its two molecules are VK2809 and VK0214. Nonetheless, companies report positive clincial data all the time and don’t run in multiples. Viking Therapeutics expects to meet with the FDA to discuss the framework for further studies. and China flared after President Trump threatened to impose new import tariffs. After 52 weeks of treatment a second biopsy is performed. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. The firm set a “buy” rating and a $14. Ligand estimates that in 2016 its partners will spend more than $1. If you are looking for a stock blog about hot stocks that are rising, you came to the right place. SanaCurrents predicted a high likelihood of success for the phase II study, and identified Viking Therapeutics as an underrated and undervalued player in the $30 billion addressable NASH market. The firm issued a buy rating and a $15. The synthesis and secretion of thyroid hormones is regulated by a negative feedback loop that involves the hypothalamus, pituitary, and thyroid. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. The study successfully achieved its primary endpoint, with patients receiving VK2809. Each of these compounds was able to reduce LDL cholesterol, but a phase 3 trial with eprotirome was interrupted because of a significant increase in liver enzymes and the contemporary report of cartilage side effects in animals. The company recently announced the filing of an Investigational New Drug (IND) application with the FDA such that a Phase 2 clinical trial of VK2809 can be performed in patients suffering from. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 12 Weeks Followed by a 4-Week Off-Drug Phase in Patients with Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease. A number of other analysts have also weighed in on VKTX. 00 price objective on the biotechnology company’s stock. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. Viking Therapeutics to Present New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress. Viking Therapeutics, Inc. The former is an orally available, tissue and. It has 52 week high of $28. VK2809 was shown to be safe and well-tolerated in the. Pipeline and Corporate Highlights. 7bn in US sales alone. Viking Therapeutics Inc (NASDAQ:VKTX) rose 16. Viking Therapeutics, Inc. VK2809 is still only in phase 2 development. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given. Viking is conducting a randomized, double-blind, placebo-controlled, parallel group Phase-2 study to determine VK2809's efficacy, safety and tolerability in patients with elevated LDL-C (low density lipoprotein - shows the level of cholesterol in blood) and non-alcoholic fatty liver disease. Protectionist trade policies have really been whipsawing the market. Much focus will be on stocks such as Viking Therapeutics, Inc. Viking also announced plans to initiate a Phase 2b study of VK2809 in biopsy-confirmed NASH in the second half of 2019. The Phase II trial was conducted in patients newly diagnosed with acute myeloid leukemia (AML) who. is the leading provider of real-time or delayed intraday stock and commodities charts and quotes. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given the uncertainty in executing a Phase 2/3 trial and the fact that essentially everyone Viking sought council from regarding the matter advised against it. Research analysts at Maxim Group started coverage on shares of Viking Therapeutics (NASDAQ:VKTX) in a research report issued on Saturday, TipRanks reports. At the median, VK2809-treated patients saw a 58. 46 on Tuesday after reporting that VK2809 met the primary and secondary endpoints in a Phase II trial to treat non-alcoholic fatty liver disease. Phase 3 trials evaluating selonsertib among NASH patients with bridging fibrosis (F3) or cirrhosis (F4) are ongoing (the STELLAR program). Lipid metabolic disorder is the most direct etiology of NAFLD. These data confirmed previously reported results. This means that VK2809 can generate truly selective activation in the liver, making the issue of targeting bias a nonissue. We will be very interested to review the data from the Phase 2 study of VK2809 in patients with hepatic steatosis/NAFLD, which we anticipate in the first half of 2018. Patients will receive either a daily dose of VK2809 or a placebo for a period of 12 weeks. The difference this time? These tariffs would serve as a punishment for China's role in the COVID-19. If VK2809 shows statistical significance in liver fat reduction, it could cement its position as one of the most promising NASH drug candidates in the industry ahead of a phase 3 study. This followed positive results for lowering of liver fat in NAFLD patients with good safety in a Phase 2 trial. patients received 10 mg VK2809 dosed every other day (QOD), and 10 mg VK2809 dosed daily (QD), respectively, for 12 weeks followed by a 4-week off-drug phase. 0, 10, 20, and 40 mg, or placebo for 14 days. The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with GSD Ia. Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of results from the company's 12-week Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with non. 12, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. The catch is that Viking may not be ready to push VK2809 into a pivotal-stage trial right now. Last year, Gilead's Selonsertib in phase III trial. Another drug -- VK5211 -- looks pretty good, too. 9% for those who received the placebo. - Additional VK2809 Phase 2 Results Selected for Podium Presentation at EASL - IND Filing for VK0214 in X-ALD Expected in 2Q20 - Balance Sheet Remains Strong, Year-End Cash Approximately $275 Million. 0, 10, 20, and 40 mg, or placebo for 14 days. Pipeline and Corporate Highlights. Actual Study Start Date : Estimated Primary Completion Date : Estimated Study Completion Date :. On April 8, 2016, Viking presented positive Phase 1b clinical data for VK2809 in patients with hypercholesterolemia. 8MM) or ($0. On November 19, 2019, Viking Therapeutics, Inc. Introduction. In addition to the impressive efficacy observed, VK2809 has also demonstrated an encouraging safety and tolerability profile. (NASDAQ:AGEN) Agenus is an immunotherapy penny stock that has had a rough start to 2020, having lost almost 50% of its value year to date. Viking Therapeutics’ product candidate VK2809 is undergoing a Phase 2 trial for the treatment of patients with hypercholesterolemia and fatty liver disease. It is developing VK0214 for the treatment of X-linked adrenoleukodystrophy (X-ALD). (VKTX) announced promising results from an in vivo study of VK2809 in a mouse model of diet-induced non-alcoholic steatohepatitis (NASH). 's (CBAY) phase 2b study. Other analysts have also recently issued research reports about the company. 17 18 The efficacy and safety of VK2809 are currently being investigated in patients with biopsy-proven NASH in the phase 2B VOYAGE clinical trial (NCT04173065). The randomized, double. VK2809 is a novel liver-selective thyroid receptor beta agonist. known as VK2809, is a thyroid receptor beta agonist that targets the liver and is being developed for lipid disorders such. 5 mg/kg/day SC was compared with no treatment (control) for 6 months in patients aged 13 to 66 years. VK2809-105: A Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of VK2809 dosed in an every-other-day (QOD) regimen. Much focus will be on stocks such as Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of new results from the company's 12-week Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with. The move translates. (2016) Role of Hedgehog Signaling Pathway in NASH. Pharmaceutical Stocks to Watch: Jazz Pharmaceuticals. Several other analysts have also issued reports on VKTX. Viking Therapeutics Inc (NASDAQ:VKTX) has been through a rough patch that likely has many long-term shareholders living in the shadow of the regret of not selling some shares back in early September, when the stock launched up to nearly test $30/share in premarket trading (almost tripling in price in a matter of hours) following the company's announcement of positive top-line results from a. 7bn in US sales alone. VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor that is entering Phase II development for the treatment of patients with hypercholesterolemia and fatty liver disease. Please read our privacy policy for more details. After reporting encouraging phase 2 drug trails for the drug VK2809 in treating patients with non-alcoholic fatty acid liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C),Viking Therapeutics is more than 50% below its highs set last year. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given the uncertainty in executing a Phase 2/3 trial and the fact that essentially everyone Viking sought council from regarding the matter advised against it. Visit http. The Phase II trial was conducted in patients newly diagnosed with acute myeloid leukemia (AML) who. Each of these compounds was able to reduce LDL cholesterol, but a phase 3 trial with eprotirome was interrupted because of a significant increase in liver enzymes and the contemporary report of cartilage side effects in animals. Oppenheimer started coverage on shares of Viking Therapeutics (NASDAQ:VKTX) in a research note issued to investors on Friday, TipRanks reports. Viking Therapeutics' fatty liver drug cuts cholesterol in phase 2. , a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders based in California, United States, announced that their VK2809 showed promising results following two months of in. The difference this time? These tariffs would serve as a punishment for China's role in the COVID-19. According to a press release from American biotechnology company Intercept Pharmaceuticals, the company recently released additional data supporting its phase 3 clinical trial of obeticholic acid (OCA) in the treatment…. The study also significantly reduced patients' liver fat content. Strong data raise hopes for Viking's VK2809 in NAFLD, NASH. VK2809 is a novel liver-selective thyroid receptor beta agonist. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given. When free fatty acids (FFAs) are either oversupplied or their disposal is damaged, they may be used as substrates for the production of lipotoxic species (e. Viking is conducting a randomized, double-blind, placebo-controlled, parallel group Phase-2 study to determine VK2809's efficacy, safety and tolerability in patients with elevated LDL-C (low density lipoprotein - shows the level of cholesterol in blood) and non-alcoholic fatty liver disease. The Zacks Equity Research reports, or ZER for short, are our in-house, independently produced research reports. VK2809 is a promising thyroid hormone receptor β-selective agonist in early phase clinical trial for metabolic disorders. Conference call scheduled for 4:30 p. The randomized, double. The difference this time? These…. This suggests VK2809’s potential therapeutic benefits. Last year, Gilead's Selonsertib in phase III trial. Pour rappel, l’essai Voyage évalue notre bêta-agoniste des récepteurs thyroïdiens à petites molécules, le VK2809, pour le traitement des patients atteints de biopsie confirmant une stéatohépatite non. Chardan Capital began coverage on shares of Viking Therapeutics (NASDAQ:VKTX) in a research report report published on Tuesday, Benzinga reports. While Viking had previously considered conducting a combined Phase 2/3 clinical trial for VK2809 in NASH, we believe that the choice to move ahead with a Phase 2b trial is the prudent one given. Last year, Gilead's Selonsertib in phase III trial and Conatus Pharmaceuticals' (CNAT) Emricasan in phase 2b trial missed their trial goals while CymaBay Therapeutics Inc. The conference runs from 10-14 April, 2019. The Zacks Equity Research reports, or ZER for short, are our in-house, independently produced research reports. VK2809 is an orally available small molecule agonist of the. 1% reduction in liver fat vs. Loomba R, Neutel J, Bernard D, et al. Phase 2 successes for Madrigal Pharmaceuticals' hormone receptor agonist MGL-3196 and Viking Therapeutics' thyroid beta agonist VK2809 led to big stock surges for both biotechs last year — though the share price for each has since trickled back down. resmetrion 80-100 mg daily § Interim subpart H endpoint: NASH resolution with at least 2 point reduction in NAS and no. The company recently announced the filing of an Investigational New Drug (IND) application with the FDA such that a Phase 2 clinical trial of VK2809 can be performed in patients suffering from. 00 per share, resulting in the gross proceeds to Viking Therapeutics of approximately $63. Metavant updated Ligand that they no longer plan to initiate a clinical proof-of-concept trial this year for RVT-1502 in Type 1 diabetes following requests from FDA for additional non-clinical studies. (NASDAQ:VKTX) is currently conducting the Phase 2b VOYAGE trial of VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH). VK2809 is still only in phase 2 development. Robust Phase 2 Data for VK2809 in NAFLD! On September 18, 2018, Viking Therapeutics, Inc. I suspect that the probability is somewhat better for VK2809 since it has already delivered positive results from the phase 2 study in NAFLD and hypercholesterolemia. Disequilibrium of lipid metabolism and the subsequent metabolic-stress-induced inflammation are believed to be central in the pathogenesis of NAFLD. VK2809‐201 is a novel liver‐directed THR‐ß agonist. VK2809, a novel liver-directed thyroid receptor beta agonist, significantly reduces liver fat in patients with non-alcoholic fatty liver disease: a phase 2 randomized, placebo-controlled trial [abstract LB-4]. SAN DIEGO, April 4, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. 's (CBAY) phase 2b study. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. 7 Thyroid hormone receptor. Viking Therapeutics doubles on Madrigal's positive phase 2 NASH results. Dosing of patients in a Phase 1 clinical trial of VK2809 in GSD Ia is expected to begin in the third quarter of 2018. Keep tabs on your portfolio, search for stocks, commodities, or mutual funds with screeners, customizable chart indicators and technical analysis. In November 2019, we initiated the VOYAGE study, a Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis, or NASH. This means that VK2809 can generate truly selective activation in the liver, making the issue of targeting bias a nonissue. VK2809 belongs to a family of novel prodrugs, which are cleaved in vivo to release. * Expect to complete ongoing phase 2 trial of VK2809 inpatients with hypercholesterolemia and fatty liver disease in1H17Source text for Eikon: Further company coverage: Read the original article. The brokerage issued a buy rating and a $9. Viking expects to release its phase 2 NASH data for VK2809 by the second half of 2018, which could potentially drive the. Viking Therapeutics, Inc. Viking is an intriguing biotech stock right now and there are some big. Treatment with asfotase alfa 0. 3Q16: VK5211 and VK2809 Phase II Programs Advancing with Potential Top-line Results in 2Q17. Study Title. april 11 (reuters) - viking therapeutics inc ::viking therapeutics presents new data from phase 2 study of vk2809 in patients with non-alcoholic fatty liver disease (nafld) and elevated. "We see the only advantage retained by Madrigal at this point being time-to-Phase 3. In June, Viking Therapeutics. Other analysts have also recently issued research reports about the company. Viking reported that the drug achieved up to 60% reduction in liver fat with up to 91% of patients taking VK2809 experiencing at least a 30% reduction in liver fat content. Even though COVID-19 has caused industry-wide delays, twelve-month biopsy data from the Phase 2b trial of VK2809 in patients with biopsy-confirmed NASH shouldn’t face much of a disruption. GS-9674 and GS-0976 are currently in Phase 2 NASH studies. Research analysts at Maxim Group started coverage on shares of Viking Therapeutics (NASDAQ:VKTX) in a research report issued on Saturday, TipRanks reports. (NASDAQ:AGEN) Agenus is an immunotherapy penny stock that has had a rough start to 2020, having lost almost 50% of its value year to date. SAN DIEGO, Oct. 0, 10, 20, and 40 mg, or placebo for 14 days. Viking Therapeutics has a 1-year low of $3. Methods: A Phase 1 study was conducted to evaluate the safety, tolerability and pharmacokinetics of VK2809 in 56 subjects with elevated serum cholesterol. The company recently submitted a pre-investigational new drug (pre-IND) meeting briefing package to the Food and Drug Administration (FDA) for VK2809 and expects to receive written feedback from the agency in the coming weeks. Based upon the data that has been presented thus far by Viking and Madrigal Pharmaceuticals, Inc. 3 Investment Highlights Focused on best-in-class drugs for metabolic and endocrine diseases -Two Phase 2 programs supported by positive clinical data Metabolic Disease Program: VK2809 for NASH -Novel, selective thyroid receptor-b(TRb) agonist -Phase 2 results demonstrate significant reduction in liver fat content, lipids. This website uses cookies to improve your experience. Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via. 88% from the company’s current price. Loomba R, Neutel J, Mohseni R, et al. The Company has completed enrollment in the Phase 2 trial of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated LDL cholesterol, and looks forward to reporting the results from this study in the fall. As a consequence, the other projects were terminated as well. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. CEO Brian Lian stated, "During Q1, we made continued progress on our Phase 2b VOYAGE clinical trial evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis. Viking Therapeutics Inc. VK2809, a Novel Liver-Directed Thyroid Receptor Beta Agonist, Significantly Reduces Liver Fat with Both Low and High Doses in Patients with Non-Alcoholic Fatty Liver Disease: A Phase 2 Randomized, Placebo-Controlled Trial Rohit Loomba1, Joel Neutel2, Rizwana Mohseni3,. The study also significantly reduced patients’ liver fat content. Dissecting the latest Phase 3 data on OCA for NASH released on Feb 19th Tickers: ICPT, GILD, VKTX, MDGL, AGN Executed On: Mar 01, 2019 at 02:30 PM EST Digging into the recent top-line data for VK2809 in treating NASH/NAFLD Tickers: VKTX , MDGL. In a little over three weeks, Viking Therapeutics Inc (Nasdaq: VKTX) will present its Phase 2 study results for its potential blockbuster drug VK2809. VK2809: Viking Therapeutics announced initiation of enrollments for NASH patients with varied stages of fibrosis for a Phase 2b efficacy and tolerability study. , a clinical-stage biopharmaceutical company, focuses on the development of novel therapies for metabolic and endocrine disorders. It has 52 week high of $28. After reporting encouraging phase 2 drug trails for the drug VK2809 in treating patients with non-alcoholic fatty acid liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C),Viking Therapeutics is more than 50% below its highs set last year. Viking reported that the drug achieved up to 60% reduction in liver fat with up to 91% of patients taking VK2809 experiencing at least a 30% reduction in liver fat content. 2 Three doses (5 mg daily [QD], 10 mg QD, 10 mg every other day [QOD]) were compared with placebo. An increase of 94% from the average daily volume of 1,417,566 shares. ET today- Enrollment Continues in Phase 2b VOYAGE Study of VK2809 in NASH- New Data from VK2809 Phase 2 NAFLD Trial to be Highlighted at EASL- IND Filing for. The Phase II trial was conducted in patients newly diagnosed with acute myeloid leukemia (AML) who. Patients were randomized to receive placebo (n = 14), 10 mg VK2809 dosed every other day (QOD, n = 15), or 10 mg VK2809 dosed daily (QD, n = 16) for 12 weeks followed by a four-week off-drug phase. Patients received either oral VK2809 doses of 10 mg QOD, or 10 mg QD, or a placebo for 12 weeks. 4, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. SAN DIEGO, April 11, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. Phase 2b VOYAGE study underway evaluating VK2809 in biopsy-confirmed NASH. Another drug -- VK5211 -- looks pretty good, too. Cited in 15,000+ publications and trusted by worldwide scientists. The firm issued a buy rating and a $12. Viking announced plans to conduct a Phase 2 trial of VK2809 in patients with hypercholesterolemia and fatty liver disease in the fourth quarter of 2015. , a clinical-stage biopharmaceutical company, focuses on the development of novel therapies for metabolic and endocrine disorders. (Viking) (VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that data from the company's 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD. According to a press release from American biotechnology company Intercept Pharmaceuticals, the company recently released additional data supporting its phase 3 clinical trial of obeticholic acid (OCA) in the treatment…. Its two molecules are VK2809 and VK0214. What were the results?. Patients were randomized to receive placebo (n = 14), 10 mg VK2809 dosed every other day (QOD, n = 15), or 10 mg VK2809 dosed daily (QD, n = 16) for 12 weeks followed by a four-week off-drug phase. Int J Mol Sci, 17: 774 2. phase III trial (NCT02704403) is currently recruiting subjects with NASH and NAS≥4, aiming to determine the effects of 72 weeks of treatment with 120 mg/day on NASH resolution without worsening of fibrosis. Viking Therapeutics Inc. VK2809-105: A Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of VK2809 dosed in an every-other-day (QOD) regimen. Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The. Clinical Programs: The company's clinical programs include: VK5211, an orally available, non-steroidal selective androgen receptor modulator (SARM) in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery; and VK2809, a small molecule thyroid beta agonist in Phase 2 development for the treatment of hypercholesterolemia. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. MRI-PDFF (magnetic resonance imaging estimation of proton density fat fraction) indicated at least 10% liver fat. The synthesis and secretion of thyroid hormones is regulated by a negative feedback loop that involves the hypothalamus, pituitary, and thyroid. Looking at the recent Phase II results for Viking's study of VK2809 in patients with NAFLD and elevated LDL-C, we can see the drug produced exceptional results. Its lead drug candidate is VK2809, an orally available tissue and receptor-subtype selective agonist of the thyroid hormone receptor beta, which is in Phase II clinical trials to treat patients with non-alcoholic fatty liver disease and elevated low-density lipoprotein cholesterol. This followed positive results for lowering of liver fat in NAFLD patients with good safety in a Phase 2 trial. Wall Street is experiencing some major déjà vu. Loomba R, Neutel J, Mohseni R, et al. In this multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2a study, we recruited adults (aged 21-75 years) with a body-mass index of at least 25 kg/m 2, biopsy-confirmed non-alcoholic steatohepatitis (fibrosis stage 1-3), and a hepatic fat fraction of at least 10% when assessed by magnetic resonance imaging-proton density fat fraction. Four compounds are in Phase 3 to date, but Tobira (Allergan) delayed their results to september 2020, to date only 3 compounds are still in course for 2019: OCALIVA (Intercept) ELAFIBRANOR (Genfit). Enrollment continues in Phase 2b VOYAGE study evaluating VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.