Ardea Biosciences Initiates Phase 2b Clinical Trial Of RDEA594

Ardea Biosciences has initiated phase 2b clinical trial of RDEA594 for the management of hyperuricemia and gout.

Reportedly, the randomized, double-blind, placebo-controlled, dose-response study will evaluate the safety and serum urate-lowering effects of 200, 400 and 600mg of RDEA594, in a total of 140 gout patients with hyperuricemia.

The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0mg/dL, following four weeks of treatment. This study will be conducted at multiple sites in Europe and North America, with initial results expected by the end of 2009.

The remaining studies in the planned phase 2 program are: a phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, and a drug-drug interaction study with febuxostat, said the company.

Barry Quart, president and CEO of Ardea, said: “Our Phase 2 program is designed to demonstrate RDEA594’s broad clinical potential in a wide spectrum of gout patients, including first-line use and as add-on therapy in patients not achieving an adequate response to either allopurinol or febuxostat, and in patients with varying degrees of renal impairment. The FDA approval of febuxostat earlier this year and the recent recommendation by the FDA’s Arthritis Advisory Committee for approval of pegloticase (Krystexxa, Savient Pharmaceuticals) for treatment-refractory gout has demonstrated the importance of new urate-lowering therapies for treatment of patients suffering from gout.”