Genfit Says Safety/Tolerability Will Give Elafibranor An Edge In NASH
Lack of pruritus and a positive cardiometabolic profile could give elafibranor an advantage as it competes with Intercept’s Ocaliva to be the first drug therapy to market in NASH. The French biotech also is working on a biomarker algorithm to optimize patient selection.
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A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.
Privately held Cirius and NGM and big pharma Bristol-Myers Squibb are in Phase II for NASH with programs also working to validate non-invasive biomarkers for diagnosis, prognosis and treatment impact.
With Intercept encountering safety concerns for Ocaliva and mixed data for Gilead's and Allergan's NASH candidates, Genfit may hold an advantage with NASH clearance ability and clean safety profile.