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Intercept Pharma Begins Phase 2 NASH Trial of OCA in Japan

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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, today announced that its partner Dainippon Sumitomo Pharma (DSP) has initiated a phase 2 clinical trial of obeticholic acid (OCA) in adult nonalcoholic steatohepatitis (NASH) patients in Japan.

The trial is studying the efficacy and safety of a once daily dose of OCA, with the goal of randomizing 200 NASH patients to receiving OCA or placebo. The primary endpoint will be evaluated by histological improvement. DSP expects to complete the trial in the first half of 2016.

Posted-In: News FDA


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