ARTICLE | Clinical News

Intercept reports more data for obeticholic acid

March 17, 2014 11:29 PM UTC

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) fell $55.10 (12%) to $407.16 on Monday after disclosing in an SEC filing late Friday that there have been 10 serious cardiovascular adverse events occurring in seven patients receiving either once-daily obeticholic acid ( OCA) or placebo in the Phase II FLINT trial to treat non-alcoholic steatohepatitis (NASH). The update came after the company received blinded safety data from NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which sponsored and conducted the 283-patient trial. Intercept said none of the adverse events were considered probably or definitely related to treatment. NIDDK said the incidence of serious cardiovascular events was numerically higher in the OCA arm compared to placebo, but the difference was not significant. In 1H15, Intercept plans to start a Phase III program evaluating OCA for NASH.

In January, Intercept surged as much as $376.66 (545%) to $445.83 after the company said the FLINT trial was stopped early after a planned interim analysis showed OCA met the primary endpoint. Intercept gave back some of the gains -- $81.47, or 18% -- after NIH released data showing lipid abnormalities in patients who received OCA in the trial (see BioCentury, Jan. 20). ...