Intercept's liver disease drug proves highly effective in study

A drug being developed by Intercept Pharmaceuticals Inc led to significant improvement in signs of a rare liver disease that primarily affects middle-aged women, likely reducing the risk of need for liver transplant and of death, according to results of a late-stage clinical trial presented on Saturday. Nearly half the patients suffering from primary biliary cirrhosis who received the drug, obeticholic acid, achieved the primary goals of the study, compared with 10 percent for those who received a placebo, researchers said. The composite main goal of the study was to achieve at least a 15 percent reduction in levels of alkaline phosphatase, a biomarker for severity of the liver disease, serum alkaline phosphatase activity of less than 1.67 times the upper limit of normal and bilirubin within normal limits. "Reduction in alkaline phosphatase is really the best prognostic factor for survival," Dr. Frederik Nevens, the study's lead investigator and chairman of the department of hepatology at the University of Leuven, in Belgium, said in a telephone interview.



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