Intercept's Ocaliva improves fibrosis in subgroup of primary biliary cholangitis patients

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) reported data from a subgroup of 13 primary biliary cholangitis (PBC) patients with liver fibrosis or cirrhosis at baseline and who had paired liver biopsies in the Phase III POISE trial showing that Ocaliva obeticholic acid for three years improved histological fibrosis stage in six patients and maintained fibrosis stage in five patients. The other two patients experienced one stage progression. Of the four patients with cirrhosis at baseline, all showed reversal by at least one stage and three patients improved to fibrosis without cirrhosis. Data were presented at the European Association for the Study of the Liver meeting in Paris.

The double-blind, international POISE trial enrolled 216 PBC patients who had an inadequate response to or who were unable to tolerate ursodeoxycholic acid (UDCA). In 2014, Intercept reported that Ocaliva met the trial’s primary endpoint vs. placebo (see BioCentury, March 24, 2014)...