- CymaBay Therapeutics (NASDAQ:CBAY) announces positive results from a Phase 2 clinical trial of seladelpar in a subset of patients with cirrhosis and primary biliary cholangitis (PBC). The data are being presented today at The International Liver Congress in Vienna.
- At week 52, cirrhotic patients who failed to respond to other treatments who received 5 mg of seladelopar once daily for 12 weeks, then increased to 10 mg (if tolerated) experienced an average decrease in alkaline phosphatase (AP) (elevated levels in the blood are associated with liver disease) of 36% from baseline. Patients receiving the 10 mg dose from the start showed a 43% reduction in AP from baseline. Seladelpar also demonstrated "robust" anti-inflammatory activity.
- A Phase 3 study, ENHANCE, is currently recruiting patients. The estimated primary completion date is December 2020.