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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While plans to obtain accelerated approval of lanifibranor remain unchanged, Inventiva now plans to conduct the confirmatory Phase III in cirrhotic patients, meaning a shorter trial duration and possibly broader label.
The French biotech was firmly on the ropes last year after elafibranor joined the long list of failures for NASH but the promise it has shown in primary biliary cholangitis has persuaded Ipsen to part with a hefty upfront fee.
After last year’s Phase III failure in NASH, Genfit sees big opportunity in acute on chronic liver failure (ACLF), potentially with antiviral NTX. Its ongoing Phase III program in PBC as also is a potential revenue-driver.