Ardea Biosciences announced positive, preliminary, top-line results from its Phase 2b study of RDEA594 in combination with the current standard of care for the treatment of gout, allopurinol. The study was a multicenter, randomized, double-blind, placebo-controlled, dose-response 28-day study that evaluated the safety and serum urate-lowering effects of RDEA594 in 208 patients with elevated uric acid levels (sUA greater than or equal to 6 mg/dL) despite being on a stable dose of allopurinol. The primary endpoint of the study was the percent reduction in sUA after 4 weeks of treatment with the combination compared to allopurinol alone. A key secondary efficacy endpoint was the proportion of patients who achieved a response, defined as a reduction of sUA below the clinically relevant target of < 6 mg/dL, after 4 weeks of combined RDEA594 and allopurinol treatment, compared to allopurinol and placebo. The primary and key secondary endpoints were achieved, with highly statistically significant reductions in sUA and up to 89% of patients taking a combination of RDEA594 600 mg and allopurinol reaching target sUA.
RDEA594 is a selective urate transporter 1 (URAT1) inhibitor.
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