RESOLVE-IT Failure Dashes Genfit's NASH Hopes
Elafibranor Missed Trial Endpoints At The Interim Stage
Genfit SA is now pinning its hopes for elafibranor on primary biliary cholangitis after the dual PPAR alpha/delta agonist failed in its Phase III RESOLVE-IT trial for NASH.
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Weeks after lifting of an FDA clinical hold, CymaBay says it will resume development of its PPAR agonist in primary biliary cholangitis. It will initiate a new Phase III trial but also use data from a terminated Phase III study.
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.
The cost-effectiveness watchdog group sees the fibrosis benefit with Intercept’s obeticholic acid as supporting use in sicker NASH patients, but its overall risk-benefit ratio doesn’t merit broader use.