NASH Drugs Update: Intercept's Phase 3 Details, Genfit's Diagnostic Tool And Raptor's Failure
Logribel Biostocks • 54 Comments
Logribel Biostocks • 54 Comments
Betting On The First NASH Blockbuster Drug: Dump Intercept And Buy Genfit
Logribel Biostocks • 71 Comments
Logribel Biostocks • 71 Comments
Wed, Apr. 6, 1:45 PM
- Gilead Sciences' (GILD +2%) acquisition of Nimbus Therapeutics for as much as $1.2B appears to have investors in a lather over other developers of therapies to treat nonalcoholic steatohepatitis (NASH), especially Galmed Pharmaceuticals (GLMD +38.3%).
- NASH-related tickers: (MNOV +0.4%)(RGLS +4.8%)(ICPT +4.4%)(CNAT +10.9%)(VBLT +3%)(GALT +2%)(TBRA -0.1%)(OTCPK:ISLT)(SHPG +7.2%)(RPTP +3.6%)(OTCPK:GNFTF -0.9%)(CANF +11.8%)
- Read now NASH Drugs: A Comprehensive Review Of Current Clinical Trials
Tue, Feb. 2, 8:02 AM
- The FDA designates privately held Cambridge, MA-based Nimbus Therapeutics' NDI-010976 for Fast Track review for the treatment of nonalcoholic steatohepatitis (NASH).
- NDI-010976 inhibits an enzyme called aceyl-COa carboxylase that plays a key role in the metabolism of fatty acids. A Phase 2 clinical trial is expected to commence in H1.
- NASH-related tickers: (NASDAQ:ICPT)(NASDAQ:TBRA)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:DRRX)(NASDAQ:CNAT)(NASDAQ:VBLT)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)(OTCPK:GNFTF)(NYSEMKT:CANF)
Nov. 16, 2015, 8:21 AM
- The design of a pivotal Phase 3 clinical trial assessing GENFIT's (OTCPK:GNFTF) lead product candidate, Fast Track-tagged Elafibranor (GFT505), for the treatment of non-alcoholic steatohepatitis (NASH) has been finalized. The study is set to commence this quarter.
- The 1,800-subject, randomized, double-blind, placebo-controlled trial will be conducted across 200 centers worldwide. The study population will include NASH patients who have a NAFLD Activity Score (NAS) of at least 4, with F2 (light) or F3 (severe) fibrosis. Participants will receive 120 mg of Elafibranor or placebo once daily. An interim analysis will be performed on the first 900 patients after 72 weeks that will support initial regulatory approval. To support full approval, the trial will continue to conclusion to show the impact of Elafibranor on the prevention of cirrhosis and other liver-related outcomes on the full study population. A group of F1 fibrotic patients who have cardiometabolic co-morbidities will be enrolled as well. The study will continue post-marketing and will remain blinded after the interim analysis. All patients will be followed until the occurrence of a pre-defined number of progressions to cirrhosis or other liver-related events.
- The primary endpoint is the resolution of NASH without worsening of fibrosis.
- NASH-related tickers: (NASDAQ:TBRA)(NASDAQ:ICPT)(NASDAQ:DRRX)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:CNAT)(NASDAQ:VBLT)(NASDAQ:RPTP)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)
Jul. 1, 2015, 11:30 AM
- Galectin Therapeutics (GALT -0.7%) announces the screening of the first five patients in its Phase 2 study, called NASH-CX, evaluating GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). The randomized, placebo-controlled study will enroll 156 patients who will receive either one of two doses of GR-MD-02 (2 mg/kg or 8 mg/kg) or placebo. Final data collection is expected in October 2017. The study completion date is February 2018.
- The primary endpoint is the reduction in hepatic portal vein pressure versus placebo as measured by the hepatic venous pressure gradient (HVPG).
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The FDA designated it for Fast Track review for the treatment of NASH in August 2013.
- NASH is one of the "next big things" for drug makers. It affects as many as 5% of Americans.
- Related tickers: (TBRA +1.7%)(ICPT -1%)(DRRX +0.4%)(MNOV +1.9%)(GLMD)(RGLS -6.3%)(AZN +1.2%)(OTCPK:GNFTF)(CNAT +4.3%)(VBLT +0.2%)(RPTP +2.7%)(LJPC +10.4%)(MRK +1.3%)(SHPG +1.4%)(OTCQB:ISLT)(GILD -0.4%)
Mar. 26, 2015, 4:21 PM
- Investors showed Intercept Pharmaceutics (NASDAQ:ICPT) some love today. Shares jumped 8% on triple normal volume in apparent response to potential competitor Genfit's (OTCPK:GNFTF) presentation of results from a Phase 2 trial of its candidate for the treatment of nonalcoholic steatohepatitis (NASH), GFT505, in a way that would make a politician proud.
- The randomized study, called GOLDEN-505, failed. The culprit was a group of early NASH patients (NAFLD Activity Score (NAS) = 3). This group, with its shockingly high placebo response rate of >57%, ruined the trial. Not to worry, though, because the problem was easily fixed by excluding the group. Using the magic of statistics on the revised population of NASH patients with NAS scores >= 4, the trial met its primary endpoint both in the global (n=274) (p=0.016) and evaluable (n=237) (p=0.027) populations, although what the specific endpoint actually was is not specified. Also, the number of responders was almost double placebo (22.4% vs. 12.7%; p=0.046).
- Genfit plans to advance GFT505 to Phase 3 development.
Mar. 11, 2015, 10:56 AM
- Biotech investors, giddy over the robust demand for hepatitis C drugs like Gilead's (GILD +0.4%) Sovaldi and Harvoni, are eagerly anticipating the next wave of new therapies for non-alcoholic steatohepatitis (NASH) or "fatty liver disease." It resembles the alcoholic variety but affects people who drink little or no alcohol. According to the NIH, it affects 2 - 5% of Americans.
- Publicly-traded companies with NASH-related development programs include: Tobira Therapeutics (RGDO +2.3%), Islet Sciences (OTCQB:ISLT), Merck (MRK -0.5%), Intercept Pharmaceuticals (ICPT +3.4%), Gilead Sciences, Shire plc (SHPG -0.6%), Galectin Therapeutics (GALT), La Jolla Pharmaceutical (LJPC -1.5%), Conatus Pharmaceuticals (CNAT -1.2%), Raptor Pharmaceutical (RPTP -1.3%), Galmed Pharmaceuticals (GLMD +1.9%) and Genfit (OTCPK:GNFTF).
- TheStreet's Adam Feuerstein says that comparing clinical trial results between firms will require scrutiny because of differences in the designs of the studies, including efficacy criteria and treatment duration. In an article published today, he compares the ongoing trials of Genfit and Intercept. Genfit's efficacy endpoint of its mid-stage study is less stringent than Intercept's but it may make it more difficult to demonstrate a statistically significant benefit versus placebo. Results from Genfit's trial are expected later this month. If positive, it should rally NASH-related stocks.
Genfit is a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions to address high unmet patient needs in metabolic and inflammatory diseases, with a particular focus on the liver and gastroenterology.