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 reduce fibrosis scores at 18 months by one stage or greater without worsening of NASH in patients with cirrhosis, also known as F4 fibrosis
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