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Ardea Biosciences Reports Recent Accomplishments and Announces Third Quarter and Year-to-Date 2009 Financial Results
Date:11/6/2009

levels less than 6 mg/dL.
  • 60% (6/10) of patients in this group who excrete less than normal amounts of uric acid in their urine responded to therapy by achieving a reduction in serum urate to levels less than 6 mg/dL after two weeks of treatment.
  • RDEA594 also produced significant reductions in serum urate in patients with mild to moderate renal impairment, with 83% (5/6) of these patients responding after two weeks of treatment. Gout patients with mild to moderate renal impairment represent a substantial portion of the gout patient population and are often not effectively treated with allopurinol.
  • RDEA594 was also well tolerated in this study, with no serious adverse events and no premature discontinuations due to adverse events in patients receiving RDEA594.
  • Ardea also presented at the ACR/ARHP meeting data from preclinical drug-drug interaction studies demonstrating RDEA594's potential to be used in combination with allopurinol and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen) and an update from a 3- and 6-month assessment of chronic toxicity in rats and monkeys, respectively, showing no organ toxicity at doses up to 300 mg/kg/day.

    • Clinical Development Efforts and Important Upcoming Clinical Development Milestones

    • All studies in our RDEA594 Phase 2 clinical development program have been initiated. These studies include a Phase 2b single-agent dose-response study evaluating the safety and urate-lowering effects of 200, 400 and 600 mg of RDEA594 in 140 gout patients (RDEA594-202), a Phase 2b combination study evaluating RDEA594 as an add-on to allopurinol in approximately 100 patients who do not respond adequately to allopurinol alone (RDEA594-203), a drug-drug interaction study with febuxostat in healthy volunteers (RDEA594-105), and a study in gout patients with renal impairment (RDEA594-204).
    • We expect to provide results
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    SOURCE Ardea Biosciences, Inc.
    Copyright©2009 PR Newswire.
    All rights reserved

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