Ardea Biosciences Inc. (RDEA) announced additional positive results from a recently completed Phase 2a study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, as well as additional positive results from the second panel of a Phase 1 drug-drug interaction and pharmacodynamic study of RDEA594 in combination with febuxostat.
The combination of RDEA594 and allopurinol reduced serum urate or sUA levels an additional 24 percent compared to allopurinol alone in the second cohort of a Phase 2a proof-of-concept study evaluating the sUA lowering effect, safety and tolerability of combining RDEA594 and allopurinol in gout patients with hyperuricemia (sUA levels of at least 9 mg/dL).
In the second panel of a drug-drug interaction and pharmacodynamic study of RDEA594 with febuxostat in healthy volunteers, 400 mg of RDEA594 QD and 40 mg of febuxostat QD reduced mean sUA levels by 49% and 45%, respectively, when used alone. The combination of RDEA594 with febuxostat resulted in about a 70% mean reduction in sUA levels compared to baseline, with intraday reductions of over 80%, reaching mean sUA levels of 1.2 mg/dL.
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