Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint

30 Sep 2022

Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.

Failed experiment — Failure in cirrhotic NASH will not scuttle Intercept's overall plans in the disease • Source: Shutterstock

The long-awaited readout from a Phase III study of Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH) patients with compensated cirrhosis revealed a missed primary endpoint, but the New York-based firm said those results will not affect its plan to refile OCA for approval in pre-cirrhotic NASH patients.

Intercept reported on 30 September that in the 916-patient Phase III REVERSE study, OCA failed at two different doses to...