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

Intercept and Axcella provide updated data on their NASH programs at the International Liver Conference, while CymaBay offers the full dataset for seladelpar in PBC.

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Companies presented new data in NASH and PBC at EASL 2020

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...

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