Intercept Pharmaceuticals Announces Completion of Enrollment in Phase 3 Primary Biliary Cirrhosis POISE Trial
Published: Dec 19, 2012
NEW YORK, Dec. 19, 2012 (GLOBE NEWSWIRE) -- 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 it has completed enrollment in POISE, its pivotal Phase 3 clinical trial of obeticholic acid (OCA) in primary biliary cirrhosis (PBC). Results from the 12-month double-blind portion of POISE are anticipated to be available in the second quarter of 2014 and, if successful, will be used to seek regulatory approval of OCA, a first-in-class FXR agonist, as a second line treatment in PBC. By enrolling 218 patients at 59 centers in 13 countries, Intercept exceeded its targeted number of patients and completed enrollment in POISE faster than originally projected.