Intercept Pharmaceuticals' (ICPT) obeticholic acid achieves its primary endpoint of reducing serum alkaline phosphatase, holding it to less than 1.67x the upper limit of normal and maintaining bilirubin within normal limits in a late-stage clinical trial for patients with primary biliary cirrhosis.
According the lead investigator a reduction in alkaline phosphatase is the best prognostic factor for survival.
The results of the 217-patient Phase 3 study (Poise clinical trial) were presented in London recently at the European Association of the Study of the Liver.
The once-per-day pill is being evaluated for the use in patients who fail to respond to ursodeoxycholic acid.
The company expects to file its applications for marketing approval in the U.S. and Europe later this year.