Intercept Pharma: NASH Primary Endpoint Met - Quick Facts

(RTTNews) - Intercept Pharmaceuticals Inc. (ICPT) announced Thursday that the FLINT trial of obeticholic acid or OCA for the treatment of nonalcoholic steatohepatitis or NASH has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met.

FLINT is a multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients over a 72-week treatment period.

The company said the decision to stop FLINT has been based on the recommendation of the Data Safety Monitoring Board or DSMB which reviewed liver biopsy data from before and at the end of the treatment period in approximately half of the 283 randomized patients, in accordance with a planned interim efficacy analysis.

The company noted that Patients enrolled in the trial were qualified based on a diagnosis determined by liver biopsy at the start of the trial with a NAFLD Activity Score (NAS) of four or greater and with a score of at least one in each component of the NAS eight point scale (steatosis 0-3, lobular inflammation 0-3, ballooning 0-2).

"The unexpected early stopping of FLINT due to OCA meeting the primary endpoint with such high significance is a major milestone," said Mark Pruzanski, Chief Executive Officer of Intercept.

Intercept stated that its collaborator Dainippon Sumitomo Pharma is currently conducting a NASH trial in Japan. This trial is evaluating the safety and efficacy of a once-daily dose of OCA as compared to placebo, with a targeted enrollment of 200 patients. Enrollment is projected to be completed by the end of January 2014 with top-line results expected by the end of 2015.