BioCentury
ARTICLE | Clinical News

Intercept's NASH therapy heads for submissions after meeting Phase III endpoint

February 22, 2019 4:57 PM UTC

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) intends to submit regulatory applications next half for obeticholic acid (OCA) after new data showed the compound met one of two primary endpoints in the Phase III REGENERATE trial to treat non-alcoholic steatohepatitis. OCA could be the first NASH treatment to reach the market.

At an 18-month analysis, the higher of two doses of OCA led to fibrosis improvement of at least one stage with no worsening of NASH in 23.1% of patients vs. 11.9% for placebo (p=0.0002), meeting one primary endpoint. Neither dose met the other primary endpoint of NASH resolution with no worsening of liver fibrosis (8% for placebo; 11.7% for high dose (p=0.1268), 11.2% for low dose (p=0.1814)). FDA required that OCA meet one of the two endpoints to satisfy the study's primary objective...