The stock price of Intercept Pharmaceuticals Inc (NASDAQ:ICPT) skyrocketed by more than 281% after the company reported that clinical trial of its liver drug, obeticholic acid (OCA) was stopped early by Data Safety Monitoring Board (DSMB) after observing clear evidences of strong efficacy.
The DSMB decided to stop the FLINT (Farnesoid X Receptor Ligand Obeticholic Acid in Nonalcoholic Steatohepatitis Treatment) trial after seeing that patients treated with OCA were getting better than those receiving a placebo. Intercept Pharmaceuticals Inc (NASDAQ:ICPT) is testing the drug to treat patients suffering from a serious chronic liver disease called nonalcoholic steatohepatitis.
According to the pharmaceutical company, FLINT is a multi-center, double-blind, placebo-controlled clinical trial, which evaluates the safety and efficacy of a 25mg oral dose of OCA administered daily for 72 weeks to biopsy-proven adult NASH patients. The National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) sponsored and conducted the trial at eight leading U.S. academic hepatology centers comprising its clinical research network (CRN).
The DSMB evaluated the liver biopsy data obtained from approximately 50% of the 283 patients before and after the end of the treatment period in accordance with a planned interim efficacy analysis. The monitoring board found that “OCA treatment resulted in a highly statistically significant improvement” in the condition of the patients.
Mark Pruzanski, M.D., Chief Executive Officer of Intercept Pharmaceutical Inc (NASDAQ:ICPT) said, “The unexpected early stopping of FLINT due to OCA meeting the primary endpoint with such high significance is a major milestone. NASH has grown to epidemic proportions worldwide, having become a leading cause of cirrhosis and liver failure. On its current trajectory, the disease is projected to become the leading indication for liver transplant.”
“We are deeply grateful to the NIDDK and the NASH CRN for their longstanding commitment both to improving our understanding of the disease and to sponsoring ambitious trials like FLINT in their quest to identify novel treatments for patients suffering from NASH,” added Dr. Pruzanski.
Intercept Pharmaceuticals In (NASDAQ:ICPT) went public in October 2012 with an offering price of $15 per share.