Form 4 INTERCEPT PHARMACEUTICAL For: May 14 Filed by: Pruzanski Mark
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Intercept Pharma (ICPT) Announces Design of OCA Phase 3 in NASH with Liver Fibrosis
May 19, 2015 6:06 AM EDTIntercept Pharma (NASDAQ: ICPT) announced its plans for an international Phase 3 trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. OCA has received breakthrough therapy designation in this patient population from the U.S. Food and Drug Administration (FDA). In accordance with harmonized advice from the FDA and European Medicines Authority (EMA), the Randomized Global Phase 3 Trial to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment (REGENERATE) has been designed as a double-blind, placebo-controlled pivotal Phase 3 clinical trial expected to... More
