CymaBay starts extension trial for seladelpar in liver disease

CymaBay Therapeutics Inc. (NASDAQ:CBAY) began a Phase II/III long-term extension trial to evaluate seladelpar (MBX-8025) in patients with primary biliary cholangitis (PBC). The open-label, international trial will evaluate daily 2, 5, and 10 mg seladelpar for up to 60 months in about 356 patients who have completed the company's Phase II trial in the indication.

The trial's primary endpoint is safety. Secondary endpoints include levels of serum alkaline phosphatase (AP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase, 5'nucleotidase, bilirubin, bone-specific AP, triglycerides, total cholesterol and high and low density lipoprotein cholesterol (HDL-C, LDL-C)...