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Genfit Not Fully Exiting NASH, Despite Terminating RESOLVE-IT

 
• By Joseph Haas

A fuller look at interim Phase III data shows no path forward to accelerated approval in NASH, company says. Genfit turns focus to developing elafibranor for PBC, as well as a NASH diagnostic.

businessman has to decide which direction is better
Genfit reached a tough decision to end RESOLVE-IT and focus on other business

Genfit SA said on 22 July that it is terminating the Phase III RESOLVE-IT study of elafibranor in non-alcoholic steatohepatitis following an in-depth review of interim data, first unveiled in May, which showed the PPAR alpha/delta agonist missed its primary endpoint of resolving NASH without worsening of fibrosis. The French firm also said it now will focus its business on two efforts: Phase III development of elafibranor for primary biliary cholangitis and advancement of its NIS4 biomarker test as an in vitro diagnostic for NASH treatment.

The interim top-line results from the pivotal NASH study were a major blow for Genfit, when they showed a 19.2% response rate for the therapeutic arm compared to 14.7% for placebo. (Also see "RESOLVE-IT Failure Dashes Genfit's NASH Hopes" - Scrip, 12 May, 2020

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