EASL Updates: Intercept Says Biomarker Data Bolster OCA’s Case For Fibrosis Benefit

The European Association for the Study of the Liver’s virtual International Liver Conference kicked off with largely incremental data in therapy areas like non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). Among the highlights, Intercept Pharmaceuticals, Inc. reported on 27 August that biomarker data from its Phase III REGENERATE study of obeticholic acid (OCA) in NASH provides further evidence that the drug can provide patients with an improvement in fibrosis, Axcella Health, Inc. presented data on its NASH candidate’s benefits on metabolism, inflammation and fibrosis, and CymaBay Therapeutics, Inc. unveiled final Phase II data for seladelpar in PBC.

Coming off a 29 June complete response letter from the US Food and Drug Administration, Intercept is preparing for a meeting with the agency, expected in the fourth quarter, in hopes of quickly refiling its new drug application for OCA to reduce fibrosis in NASH patients. (Also see "Intercept’s CRL Just Continues Upheaval In NASH" - Scrip, 29 June, 2020