The lead drug in NASH bites the dust. Genfit, t
Post# of 148169
Genfit, the perceived leader in NASH disclosed interim analysis after a long trial looking for NASH-fibrosis improvement:
Quote:
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.
This leaves Intercept, Galectin, Biking and CytoDyn still in the race. NASH is a VERY difficult condition to treat and the winner will take a very large price ($20B-$35B).
This makes our NASH proof-of-concept study much more valuable.