Genfit's Enrollment Delay In NASH May Aid Intercept's First-To-Market Goal

Firm cites heavy competition for NASH patients, as well as desire for balanced enrollment in elafibranor pivotal study. Competitor Intercept pushed back its Phase III enrollment timeline this past February.

Genfit SA's announcement April 24 that it will need more time to enroll the first 1,000 patients in a Phase III study for its non-alcoholic steatohepatitis (NASH) candidate elafibranor likely increases the edge Intercept Pharmaceuticals Inc. already had in reaching the market first with its own Phase III candidate, Ocaliva (obeticholic acid).

First to market probably won't determine the ultimate winner in the NASH sweepstakes, but both companies, the first to reach Phase III in the indication, covet the possibility. (Also see "The NASH Pipeline: Replete With Targets And New Compounds" - Scrip, 29 August, 2016.) Numerous companies are targeting the unmet medical need, as evidenced by the clinical trial and biomarker data in NASH presented during the European Association for the Study of the Liver conference in Amsterdam, April 20-23

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