DiagnosticsArdea Biosciences Initiates Phase 2b Clinical Trial Of RDEA594, Lead Product Candidate For The Treatment Of Gout
Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced that it has initiated a Phase 2b clinical trial of RDEA594, its lead product candidate in development for the management of hyperuricemia and gout. The Company also announced the selection of RDEA684, a next-generation URAT1 inhibitor, as a development candidate for the same indication.
The randomized, double-blind, placebo-controlled, dose-response study will evaluate the safety and serum urate-lowering effects of 200, 400 and 600 mg of RDEA594 in a total of 140 gout patients with hyperuricemia (uric acid levels of 8 mg/dL or more). The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0 mg/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, including a Phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, a drug-drug interaction study with febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen), and a study in patients with renal impairment, are expected to begin shortly.
"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," commented Barry D. Quart, Pharm.D., Ardea"s president and chief executive officer. "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."
About RDEA594 and RDEA684
RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, is a selective URAT1 transporter inhibitor that has successfully completed a Phase 2a proof-of-concept study in gout patients with hyperuricemia, as well as single- and multiple-ascending-dose Phase 1 studies in normal, healthy volunteers. Over 300 people have safely received RDEA594, either by direct administration or through administration of RDEA806, its prodrug. RDEA684, a next-generation URAT1 inhibitor, has been selected as a development candidate and has entered preclinical development in anticipation of a first-in-human clinical trial, which is expected to begin in 2010. Based on preclinical results, RDEA684 demonstrates many of the same positive attributes as RDEA594, but with more than 170-times greater potency against the URAT1 transporter.
Ardea Biosciences, Inc.