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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

who achieved a response, defined as a reduction of sUA below the clinically relevant target of < 6 mg/dL, after 4 weeks of combined RDEA594 and allopurinol treatment, compared to allopurinol and placebo.

Reductions in sUA and response rates increased in a dose-related manner when RDEA594 was combined with allopurinol and were highly clinically and statistically significant at all dose levels when compared to allopurinol alone.  At the highest dose tested of 600 mg, there was a 30% mean reduction in sUA levels after 4 weeks, compared to a 3% mean increase on placebo (p < 0.0001).  This resulted in a response rate of 79% for the 600 mg dose (p < 0.0001) using the more rigorous "intent-to-treat" (ITT) analysis, which considers all patients without efficacy results at Week 4 as non-responders, including those who discontinue for any reason.  Using a "last observation carried forward" (LOCF) analysis, which was the analysis method used for the approval of Uloric®, the response rate for the 600 mg dose group was 89% (p < 0.0001).Preliminary, Top-Line Efficacy Results of Phase 2b Combination Therapy Study of RDEA594 in Allopurinol-Refractory Patients with GoutTreatment GroupsRDEA594 600mg qd + allopurinol

RDEA594 400mg qd + allopurinol

RDEA594 200mg qd +allopurinol

Placebo qd + allopurinolResponse Rate

(ITT Analysis)79%

(n=48)p< 0.000174%

(n=42)p< 0.000163%

(n=46)p< 0.0001

25%

(n=72)Response Rate

(LOCF Analysis)89%

(n=45)p<0.000176%

(n=42)p<0.000171%

(n=45)p<0.0001

29%

(n=70)Mean Change in Serum Urate at Week 4 vs. Baseline on Allopurinol Alone-30%p< 0.0001-22%p< 0.0001-16%p< 0.0001

+3%p-values versus allopurinol + placeboThe combination of RDEA594 and allopurinol was well tolerated in this study.  The only serious adverse event in the study, a fatal myocardial in
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SOURCE Ardea Biosciences, Inc.
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