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January 7, 2013
17:37 EDTICPTIntercept Pharmaceuticals initiates Phase 2 NASH tiral of OCA in Japan
Intercept Pharmaceuticals announced that its partner Dainippon Sumitomo Pharma, or DSP, has initiated a phase 2 clinical trial of obeticholic acid, or OCA, in adult nonalcoholic steatohepatitis, or 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.
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