Intercept Pharmaceuticals, Inc. provided a clinical update on obeticholic acid (OCA), a novel bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR), currently being developed in a Phase 3 trial for primary biliary cirrhosis (PBC), as well as Phase 2 trials for several chronic indications including nonalcoholic steatohepatitis (NASH), portal hypertension and bile acid diarrhea (BAD), together with projected 2014 anticipated milestones. POISE is a double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of a once daily dose of OCA in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodiol. In December 2013, the last patient follow-up visit was completed, marking the conclusion of the double-blind phase of the POISE trial.

Of the 217 patients randomized, 19 patients (approximately 9%) discontinued early, including seven patients (approximately 3%) who did so due to pruritus. Top-line results from the double-blind phase of the POISE trial are expected to be available in the second quarter of 2014.