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VIDEO: Seladelpar met phase 2 alkaline phosphatase endpoint in PBC

VIENNA — In this exclusive video from the International Liver Congress 2019, Marlyn J. Mayo, MD, from The University of Texas, presents positive data from a phase 2 study of seladelpar in patients with primary biliary cholangitis and compensated cirrhosis.

The study comprised 119 patients who received at least one dose of seladelpar, 26 of whom had compensated cirrhosis. In the subgroup of patients with cirrhosis, 15 patients received 5 mg with dose-escalation to 10 mg when the alkaline phosphatase threshold was not met, and 11 patients received 10 mg throughout the study.

Mean decreases in alkaline phosphatase were –25% in the dose-escalation group and –39% in the 10 mg group at 3 months, –24% and –41% at 6 months, and –36% and –43% at 1 year. After 1 year of treatment, all patients in the dose-escalation group and three of five patients in the 10 mg group had alkaline phosphatase less than 1.67 times the upper limit of normal.

Median decreases in alanine aminotransferase were –31% in the dose-escalation group and –50% in the 10 mg group. Median absolute changes in pruritus visual analogue scale were 0 in the does-escalation group and –25 in the 10 mg group.

“When looking at pruritus, or itching, we saw no worsening of pruritus in either the cirrhotics or the non-cirrhotics,” Mayo said. “There was kind of a hint that it was getting better but since it was an open-label study we can’t say for sure.”

Reference: Mayo MJ. PS-122. Presented at: International Liver Congress; April 10-14, 2019; Vienna, Austria.

Disclosure: Mayo reports she has received grant support from CymaBay Therapeutics.