ARTICLE | Clinical News

Intercept reports NASH data from Japanese study

October 29, 2015 2:41 AM UTC

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) slipped $3.51 to $164.13 on Wednesday after reporting data from a Phase II trial of obeticholic acid ( OCA; DSP-1747) in Japanese non-alcoholic steatohepatitis (NASH) patients. Intercept's partner Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) conducted the trial.

In the 200-patient study, a significantly higher percentage of patients receiving 40 mg of OCA once daily achieved histologic improvements at week 72 compared to placebo (p=0.0496), meeting the primary endpoint. Patient groups receiving 10 mg or 20 mg of OCA once daily did not meet the primary endpoint (p=0.807 and p=0.3378, respectively). The trial defined histologic improvement as at least a two-point improvement in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) with no worsening of fibrosis. ...