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news.Metabolex has started a randomized, double-blind, placebo-controlled Phase 2 study to evaluate arhalofenate (MBX-102) for the management of hyperuricemia in patients with gout.
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In the trial, the company will investigate the safety and urate-lowering activity of arhalofenate 400mg and 600mg in around 60 patients with hyperuricemia.
Arhalofenate’s eight Phase 1 and four Phase 2 studies have demonstrated safety and tolerability in more than 550 patients for up to six months of treatment.
Additionally, Metabolex will also be initiating a combination study with allopurinol in patients refractory to allopurinol and a combination study with febuxostat (Uloric, Takeda Pharmaceutical , Adenuric, Ipsen and Menarini).
Metabolex president and CEO Harold Van Wart said their Phase 2 program is designed to show that arhalofenate has a broad clinical profile for the treatment of hyperuricemia and gout including first-line use and, for patients not reaching treatment goals, in combination with allopurinol or febuxostat.
"Advancing the development of arhalofenate has the potential to significantly improve the lives of patients suffering from gout," Wart said.