Shares of Intercept Pharmaceuticals (ICPT - Free Report) surged a whopping 281.09% in regular trading after the company announced that the FLINT (Farnesoid X Receptor Ligand Obeticholic Acid in Nonalcoholic Steatohepatitis Treatment) trial on its lead pipeline candidate, obeticholic acid or OCA was stopped early after the study met its primary endpoint.
The multi-center, double-blind, placebo-controlled phase II trial, FLINT (n=283), is evaluating the efficacy and safety of OCA for the treatment of nonalcoholic steatohepatitis (NASH).
The trial is being sponsored and conducted by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK).
The Data Safety Monitoring Board (DSMB) reviewed liver biopsy data through the trial in approximately half of the randomized patients and recommended to stop the trial. The data from the trial showed that treatment with OCA resulted in a highly statistically significant improvement as compared to placebo, thereby meeting the primary endpoint.
The news comes as a major milestone for Intercept Pharma as OCA is its lead candidate. Intercept Pharma primarily focuses on the development and commercialization of novel therapeutics to treat chronic liver diseases.
Apart from NASH, OCA is being evaluated for other indications like primary biliary cirrhosis (PBC), portal hypertension and bile acid diarrhea (BAD).
We note that OCA enjoys orphan drug status in the U.S. and EU for the treatment of PBC. Intercept owns worldwide rights to OCA except in Japan and China, where it has out-licensed the product candidate to Dainippon Sumitomo Pharma.
Concurrent with the results from the FLINT trial, Intercept Pharma announced that it has obtained positive clinical data in all six phase II clinical trials in five different indications for OCA. The company expects data from POISE and FLINT trials in 2014, followed by the anticipated completion of the New Drug Application (NDA) and Marketing Authorisation Application (MAA) filings for PBC by 2014 end.
Intercept Pharma also announced positive top-line results from the OBADIAH study which is evaluating whether OCA can stimulate the release of FGF19 in patients suffering from primary BAD (PBAD) and preliminary data from the PESTO trial evaluating OCA for portal hypertension.
Intercept Pharma currently does not have any approved drug in its kitty. Hence, we expect investor focus on OCA updates for the PBC (POISE trial) and NASH (FLINT trial) indications.
Intercept Pharma currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the same sector include Actelion (ALIOF - Free Report) , Amicus Therapeutics (FOLD - Free Report) and Celgene Corp. (CELG - Free Report) . While Actelion is a Zacks Rank #1 (Strong Buy) stock, the other two stocks carry a Zacks Rank #2 (Buy).