Posted by Michael Wonder on 15 Feb 2019
CymaBay Therapeutics announces seladelpar granted breakthrough therapy designation by the FDA for the treatment of primary biliary cholangitis
15 February 2019 - CymaBay Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for seladelpar for the treatment of early stage primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adult patients with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Seladelpar is an orally administered, potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently being evaluated in a global, Phase 3 registration study, ENHANCE, for patients with PBC.
The breakthrough therapy designation of seladelpar was granted based on preliminary evidence from the ongoing Phase 2 clinical trial (CB8025-21629), which indicates that seladelpar may demonstrate substantial improvement over existing therapy based on a reduction in alkaline phosphatase.
