The results were from the ongoing Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC), a life-threatening and life-limiting chronic cholestatic liver disease.
Seladelpar is in development for the treatment of liver diseases PBC and Nonalcoholic steatohepatitis (NASH).
After sharing preliminary results from this study, the FDA has agreed to allow continuation of seladelpar treatment beyond six months for the 5 mg and 10 mg doses, the group revealed.
"The data emerging from this study are impressive and support our hypothesis that lower doses of seladelpar than previously studied retain strong efficacy without raising a concern with transaminase elevations," said Professor Gideon Hirschfield, Centre for Liver Research at the University of Birmingham, UK
"We also see that seladelpar activity is not associated with drug-induced itch, an important benefit for patients with PBC. If these results are maintained over longer periods, we think that seladelpar could offer patients significant advantages over existing treatments," he added.