RE:RE:RE:RE:Genfit did not meet primary end point in NashSeems to me the FDA accepted Genfit's primary endpoint of "
achieving NASH resolution without worsening of fibrosis". This is comparable to Thera's proposed end point .
Note that Grimpson' s study results for this endpoint is fibrosis progression percentage is 10.5% on treatment group vs 37.5% on control arm (placebo cohort) (P= 0.004).
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Genfit's elafibranor flunks NASH study; shares plummet 42% after hours
Based on an interim analysis, a Phase 3 clinical trial, RESOLVE-IT, evaluating Genfit's (NASDAQ:GNFT) elafibranor in adults with nonalcoholic steatohepatitis (NASH) failed to achieve the primary endpoint.
Elafibranor did not sufficiently separate from placebo as measured by the proportion of patients achieving NASH resolution without worsening of fibrosis at week 72. Based on an intent-to-treat population of 1,070 patients, the response rate in the treatment group was 19.2% (n=138/717) compared to 14.7% (n=52/353) in the control arm.
The proportion of patients achieving improvement in fibrosis at week 72, a secondary endpoint, was 24.5% in the treatment arm versus 22.4% in the control arm.
The full dataset will be presented at a liver meeting in H2.
Shares down 42% after hours.
Selected NASH-related tickers: Intercept Pharmaceuticals (NASDAQ:ICPT) (+3%); Galectin Therapeutics (NASDAQ:GALT) (+12%); Viking Therapeutics (NASDAQ:VKTX) (-3%); Can-Fite BioPharma (NYSEMKT:CANF) (-1%); Lipocine (NASDAQ:LPCN) (+4%); Bristol-Myers Squibb (NYSE:BMY) (-1%)