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Ardea Biosciences Announces Positive Top-Line Results from Phase 2b Combination Study of RDEA594 in Allopurinol-Refractory Gout Patients
Date:1/6/2011

SAN DIEGO, Jan. 6, 2011 /PRNewswire/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced positive, preliminary, top-line results from its Phase 2b study of RDEA594 in combination with the current standard of care for the treatment of gout, allopurinol.  Allopurinol currently accounts for greater than 90% of the unit sales of chronic gout prescription medications; however, in controlled trials, only 30-40% of gout patients respond adequately to allopurinol as defined by the achievement of a serum uric acid (sUA) level of less than 6 mg/dL, the medically recommended target.  In this Phase 2b study, the primary and key secondary endpoints were achieved, with highly statistically significant reductions in sUA and up to 89% of patients taking a combination of RDEA594 600 mg and allopurinol reaching target sUA.  RDEA594, Ardea's lead product candidate for the chronic treatment of gout, is an orally administered compound that inhibits the URAT1 transporter, a biological mechanism that is complementary to the mechanism of allopurinol and that of the most recently approved oral drug for gout, febuxostat (Uloric ®).

This was a 28-day, randomized, double-blind, placebo-controlled, study conducted in 208 gout patients with elevated uric acid levels (sUA greater than or equal to 6 mg/dL) despite being on a stable dose of allopurinol.  In the study, patients remained on a stable dose of allopurinol and also received once daily doses of 200 mg RDEA594, 400 mg RDEA594, 600 mg RDEA594 or placebo.  For patients randomized to receive 400 mg RDEA594 and 600 mg RDEA594, the RDEA594 daily dose was escalated weekly in increments of 200 mg/day.  The primary endpoint of the study was the percent reduction in sUA after 4 weeks of treatment with the combination compared to allopurinol alone.  A key secondary efficacy endpoint was the proportion of patients
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SOURCE Ardea Biosciences, Inc.
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