Intercept says liver disease drug effective in trial
Intercept Pharmaceuticals Inc said on Sunday its experimental liver disease drug was effective in a third late-stage clinical trial and that the results set the stage for the company to file for marketing approval. The drug, obeticholic acid (OCA), is designed to treat primary biliary cirrhosis, a disease in which bile ducts in the liver become damaged, allowing harmful substances to build up and scar liver tissue. The findings come roughly two months after a clinical trial of the drug in patients with nonalcoholic steatohepatitis, a disease characterized by a buildup of fat in the liver, was halted early because the drug was working better than expected. The latest trial, known as POISE, indicates “that OCA clearly produced clinically meaningful improvements,” said Professor Frederik Nevens, chairman of the department of hepatology at the University of Leuven in Belgium and the lead investigator on the trial.