Intercept Pharmaceuticals Completes Enrollment in Phase 3 Primary Biliary Cirrhosis POISE Trial
Intercept Pharmaceuticals (NASDAQ: ICPT) (Intercept) 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.
"We are delighted that POISE is fully enrolled ahead of schedule and believe this reflects the enthusiasm of both the investigators and patients for a new treatment option," commented David Shapiro, MD, Intercept's Chief Medical Officer.
About Primary Biliary Cirrhosis and the POISE Trial
PBC is an autoimmune liver disease that may progress to cirrhosis and liver failure, and it is currently the fifth leading indication for liver transplant in the United States. It is primarily