CymaBay reports Phase II data for lower doses of seladelpar in PBC

CymaBay Therapeutics Inc. (NASDAQ:CBAY) reported interim data from 24 patients with primary biliary cholangitis (PBC) in a Phase II trial showing that once-daily 5 and 10 mg doses of oral seladelpar (MBX-8025) significantly reduced alkaline phosphatase levels from baseline to week 12 by 39% and 45%, respectively. Additionally, 45% and 82% of patients receiving low- and high-dose seladelpar achieved alkaline phosphatase levels of <1.67 times the upper limit of normal. No serious adverse events were reported and no safety transaminase signal was observed at either dose.

The open-label, international trial is evaluating once-daily 5, 10 and 25 mg doses of seladelpar in about 36 PBC patients who had an inadequate response or are intolerant to ursodeoxycholic acid. The trial's primary endpoints are the change from baseline in serum alkaline phosphatase levels and safety. Secondary endpoints include measurements of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), 5’-nucleotidase, bilirubin, triglycerides, total cholesterol, HDL-C and LDL-C, 5-D itch scale, pruritus visual analog score (VAS) and quality of life (QOL)...