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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

farction, occurred on allopurinol alone.  No serious adverse events or deaths occurred while patients were on RDEA594. Adverse events were infrequent, not dose related and comparable between the groups receiving RDEA594 and placebo.  Five patients discontinued treatment due to an adverse event; three occurred on allopurinol alone and two occurred on the combination of allopurinol and RDEA594.  Preliminary Safety Results of Phase 2b Combination Therapy Study of RDEA594 in Allopurinol-Refractory Gout Patients

Percent of Patients with Treatment-Related Adverse Events Occurring in More Than One Patient Treatment GroupsRDEA594 600mg qd + allopurinol

RDEA594 400mg qd + allopurinol

RDEA594 200mg qd + allopurinol

RDEA594 All Doses + allopurinol

Pooled Placebo + allopurinolNumber of patients

48

42

46

136

72Any Adverse Event

10.4%

9.5%

2.2%

7.4%

13.9%Diarrhea

0%

2.4%

0%

0.7%

2.8%Dyspepsia

2.1%

0%

0%

0.7%

1.4%Dizziness

0%

0%

2.2%

0.7%

2.8%Lipase Increased

0%

2.4%

0%

0.7%

1.4%Hematuria

0%

2.4%

0%

0.7%

2.8%"The encouraging safety and efficacy results from this multi-center, randomized study of RDEA594 in combination with allopurinol provide a strong basis to advance this innovative product into Phase 3 clinical development," commented John S. Sundy, MD, PhD, Associate Professor of Medicine and Director of the Duke Clinical Research Unit at Duke University Medical Center.  "There is a major unmet medical need for a well-tolerated, orally administered urate-lowering therapy that works by a novel mechanism of action and can be given alone or in combination with other agents to the many patients who are not adequately treated with currently available products."

"We are very please
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SOURCE Ardea Biosciences, Inc.
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