Intercept initiates phase 3 trial of obeticholic acid for NASH

Intercept Pharmaceuticals announced its launch of a global, pivotal phase 3 clinical trial, the REGENRATE trial, a study of obeticholic acid for the potential treatment of nonalcoholic steatohepatitis, according to a press release.

The phase 3 trial will evaluate the impact of obeticholic acid (OCA) therapy on approximately 2,500 patients with NASH patients and stage 2 or stage 3 advanced liver fibrosis, to determine any benefit of OCA treatment on liver-related clinical outcomes. The patients will be randomly assigned to receive either placebo, 10 mg of OCA or 25 mg of OCA, once daily, according to the release.

“We are very pleased to announce the key aspects of our planned phase 3 REGENERATE trial today, a culmination of our analyses of the FLINT trial results in OCA-treated NASH patients with advanced liver fibrosis and extensive collaboration with U.S. and European regulatory agencies,” Mark Pruzanski, MD, president and chief executive officer of Intercept, said in the release. “There are no approved medicines available to treat the disease which is why NASH is predicted to become the leading indication for liver transplant within the next few years.”

The trial will be conducted at 250 centers across North America, Europe and other regions and will include a pre-planned interim histology analysis after 72 weeks of treatment in approximately 1,400 patients, which is intended to serve as the basis for seeking U.S. and international marketing approvals of OCA for the treatment of NASH patients with liver fibrosis, according to the release.

The release further states that an additional cohort of patients with NASH and stage 1 early liver fibrosis with an increased risk of rapid progression due to concomitant diabetes, obesity or active liver inflammation, will also be enrolled, but not included in the primary endpoint analyses.

The trial is expected to begin in the third quarter of 2015. – by Melinda Stevens

Disclosure: Pruzanski reports being employed by Intercept.