Intercept falls on Phase III NASH trial design

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) shed $50.48 (16%) to $263.50 on Tuesday after announcing the design of its Phase III REGENERATE trial of obeticholic acid ( OCA) to treat non-alcoholic steatohepatitis (NASH).

Intercept expects the trial will begin in 3Q15 and will enroll 2,500 NASH patients with advanced liver fibrosis who will receive placebo or 10 mg or 25 mg of OCA once daily. The company said data from a planned interim analysis in 1,400 patients after 72 weeks will serve as the basis for global regulatory submissions. ...