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news.CymaBay Therapeutics has completed its end-of-phase 2 discussions with the US Food and Drug Administration (FDA) on the phase 3 development program for its arhalofenate gout candidate.
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Arhalofenate is a novel dual-acting product candidate for the treatment of gout that lowers serum uric acid (sUA) and reduces gout flares.
It inhibits a renal uric acid transporter called URAT1 to lower sUA by blocking the reabsorption of uric acid in the proximal tubules of the kidney.
Arhalofenate is the first compound in a new class of investigational gout therapy that the company refers to as urate lowering anti-flare therapy. It is being developed as a combination product with febuxostat.
The program will feature two phase 3 studies of arhalofenate, in combination with febuxostat in patients with chronic gout and a third trial in patients with more advanced disease called tophaceous gout.
About 1,300 patients will be enrolled in the phase 3 program. Each study will have a treatment period of about 12 months.
The co-primary endpoints will be responder rates and flare rates. The trials are expected to start later this year.
CymaBay CEO Harold Van Wart said: "We are very pleased with the positive outcome and constructive advice received from the FDA during our end-of-Phase 2 discussions.
"We now have clear direction as to how to conduct a Phase 3 program that could capture the dual benefits of arhalofenate in two separate patient populations with gout."
Arhalofenate has demonstrated two therapeutic actions in a single drug in several phase 2 gout studies.