Intercept Pharmaceuticals Says Data Show Improvement in Liver Fibrosis in PBC Patients

Intercept Pharmaceuticals said Friday that data from a phase 3 trial of Ocaliva in patients with primary biliary cholangitis showed a reduction in liver stiffness compared to placebo.

The data will be presented at the American Academy for the Study of Liver Diseases in Boston between Nov. 11 and Nov. 15.

A second presentation evaluated the efficacy and safety of Ocaliva in a subset of patients with cirrhosis who were at the greatest risk of progression to liver-related adverse outcomes or death. Intercept said that at month 12, more Ocaliva-treated patients with cirrhosis achieved the primary composite study endpoint compared to placebo.

Finally, a third presentation shows that Ocaliva demonstrated comparable efficacy regardless of renal status and enabled patients with renal impairment to achieve significant improvements in markers of cholestasis and hepatic damage. The company said the treatment had no apparent effect on renal safety, with mild to moderate pruritus the most commonly occurring adverse event in all renal function groups.

Leave a Comment