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 for the treatment of patients with non-alcoholic steatohepatitis (NASH). A Phase 2 study of seladelpar demonstrated clinical activity and established proof-of-concept in PBC. A second Phase 2 study to support dose selection for Phase 3 development is ongoing. We are also conducting a Phase 2b proof-of-concept study of seladelpar for the treatment of NASH.
Seladelpar has received orphan drug designation for PBC by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and also has PRIority Medicines (PRIME) designation from the EMA for the treatment of PBC.
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 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.