Ardea Biosciences, Inc. (RDEA)

[surf1944]

On 7/20/09, Ardea Biosciences (RDEA) 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 (marketed as Uloric by Takeda Pharma and Adenuric by Ipsen), and a study in patients with renal impairment, are expected to begin shortly.

http://seekingalpha.com/article/150218-fda-calendar-updates-staar-surgical-spectrum-pharma-allergan-incyte-ardea?source=yahoo