Intercept Pharmaceuticals, Inc.
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.
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