Arhalofenate is a urate-lowering anti-flare therapy that has completed Phase 2 and is ready to advance to Phase 3 as a novel potential treatment for gout. Arhalofenate has been found to reduce painful flares in joints while at the same time lowering serum uric acid by promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia.
In December 2016, we entered into an exclusive licensing agreement with Kowa Pharmaceuticals America, Inc. (Kowa) for the development and commercialization of arhalofenate in the United States. Kowa is responsible for all development and commercialization costs in the U.S. Under the terms of the agreement, CymaBay is eligible to receive milestones and royalties. CymaBay retains full development and commercialization rights outside the U.S. and intends to partner in those geographies.
Arhalofenate has been studied in five Phase 2 clinical trials in patients with gout and consistently demonstrated the ability to reduce gout flares and reduce serum uric acid (sUA). Gout flares are recurring and painful episodes of joint inflammation that are triggered by the presence of monosodium urate crystals that form because of elevated sUA levels. We believe the potential for arhalofenate to prevent or reduce flares while also lowering sUA could differentiate it from currently available treatments for gout and classify it as the first potential drug in what we believe could be a new class of gout therapy referred to as Urate Lowering Anti-Flare Therapy (ULAFT).
Arhalofenate has established a favorable safety profile in clinical trials involving over 1,100 patients exposed to date. We have previously completed end-of-Phase 2 discussions with the FDA and scientific advice discussions with the EMA who have provided input on the potential Phase 3 program.