We are a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need.
Seladelpar is a potent, selective, orally active PPARδ agonist currently in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC) and the epidemic in NonAlcoholic SteatoHepatitis (NASH). A Phase 2 study of seladelpar demonstrated clinical activity and established proof-of-concept in PBC. We are now conducting a second Phase 2 study to support dose selection for Phase 3 development. Seladelpar has received an orphan designation from the U.S. Food and Drug Administration and the PRIority MEdicine (PRIME) status from the European Medicines Agency. Clinical development for NASH is currently being planned.
Arhalofenate is a potential urate-lowering anti-flare therapy for gout that is Phase 3 ready. In December 2016, Kowa Pharmaceuticals America, Inc. licensed U.S. rights for arhalofenate and is responsible for all development and commercialization costs in the U.S. CymaBay retains full development and commercialization rights for outside the U.S. and intends to partner in those geographies.
Our pipeline also includes additional investigational products and lead candidates for liver and other chronic diseases.