Intercept Pharmaceuticals, Inc. ICPT announced its plans to conduct a phase III study on its lead candidate obeticholic acid (OCA) for the treatment of patients suffering from non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

The company designed the Randomized Global Phase 3 Trial to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment (REGENERATE) following the requirements of the FDA and the EMA. REGENERATE will be a double-blind, placebo-controlled pivotal study on OCA to evaluate the potential benefit of OCA on liver-related outcomes in patients suffering from  stage II or stage III advanced liver fibrosis.

Intercept Pharma intends to use data from a pre-planned interim histology analysis of the study (after 72 weeks of treatment) as the basis of filing for OCA’s approval in the U.S. as well as ex-U.S. markets for the treatment of NASH patients with liver fibrosis. OCA enjoys breakthrough therapy status for this indication in the U.S. The company’s shares fell 16.1%, reflecting investor reaction to the size of the trial.

Meanwhile, OCA is being developed for a variety of chronic liver diseases apart from NASH – primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC) and biliary atresia. The development program for PBC is Intercept Pharma’s most advanced program on OCA. Currently, the company is making a rolling submission of a new drug application for OCA for PBC and intends to complete the submission by Jun 2015. Intercept Pharma also intends to file for OCA’s approval in Europe during this period. OCA enjoys fast track and orphan drug status in the U.S. and orphan drug designation in the EU for PBC. Additionally, the candidate enjoys orphan drug status for PSC in both the U.S. and the EU.

We note that Galmed Pharmaceuticals GLMD is conducting a phase IIb study on aramchol for the treatment of NASH patients, who suffer from obesity and insulin resistance. Top-line data should be out by the end of 2016.

Intercept Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Actelion Ltd. ALIOF and Gilead Sciences Inc. GILD. Both sport a Zacks Rank #1 (Strong Buy).

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