CymaBay announces publication results from ENHANCE Phase 3 study

CymaBay Therapeutics announced that results from the ENHANCE phase 3 global study evaluating seladelpar for primary biliary cholangitis have been published in Hepatology: This double-blind, placebo-controlled, global phase 3 study evaluated the efficacy and safety of seladelpar, a potent, selective, orally active PPARdelta agonist, or delpar, after 3 months of treatment in patients with PBC. Patients with elevated alkaline phosphtase received treatment as an add-on to first line ursodeoxycholic acid, or as monotherapy, if patients were intolerant to UDCA. All pre-specified endpoints were assessed after 3 months in patients receiving oral daily seladelpar 5 mg, 10 mg or placebo. The primary endpoint was a composite of alkaline phosphatase and bilirubin2 previously accepted by FDA for pivotal studies in PBC. The composite endpoint was achieved in 78.2% of patients on seladelpar 10 mg and 57.1% on seladelpar 5 mg versus 12.5% on placebo. A key secondary endpoint of having normal levels of alkaline phosphatase was met in 27.3% and 5.4% in seladelpar 10 mg and 5 mg groups, respectively, versus none in the placebo group. The final key secondary endpoint assessed the patient-reported symptom of pruritus using a daily pruritus numerical rating scale. Statistically significant improvement in pruritus for patients with moderate-to severe itch was demonstrated for seladelpar 10 mg versus placebo. Patients taking seladelpar also had significant improvements in markers of liver injury. There were no treatment related adverse endpoints in the study.