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news.Ardea Biosciences has received regulatory approval to begin a Phase IIa proof-of-concept clinical trial evaluating RDEA806 in gout patients with hyperuricemia.
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The Phase IIa randomized, double-blind, dose ranging, efficacy and safety trial will be conducted in academic medical centers in Europe and Canada. In this trial, the company plans to evaluate the serum uric acid (sUA) level, pharmacokinetics, safety and tolerability of two different dose regimens of RDEA806 versus placebo in establishing normal sUA concentrations in gout patients with hyperuricemia (greater than or equal to 8mg/dl).
The primary efficacy endpoint is the proportion of subjects whose sUA level is less than 6mg/dl following four weeks of treatment.
The company has also announced that gout specialist, Fernando Perez-Ruiz in Spain, will be the newest member of its inflammatory disease scientific advisory board.
Barry Quart, president and CEO of Ardea Biosciences, said: “The Phase IIa trial should allow us to confirm RDEA594’s activity in the target population of patients with gout using its prodrug, RDEA806. Enrollment in the Phase IIa trial should begin shortly and we are on track to initiate a Phase I trial with RDEA594 in the second half of 2008.”