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Ardea Biosciences Provides Additional Results From a Phase 2b Study of Lesinurad in Combination With Allopurinol at the Annual European Congress of Rheumatology
Date:5/25/2011

onths.

Final results were also presented from the completed 28-day main portion of study 203. At the highest lesinurad dose tested in this study, patients achieved a 30 percent mean reduction in sUA levels after 4 weeks, compared to a 3 percent mean increase on allopurinol plus placebo (p< 0.0001).  This resulted in a response rate of 79 percent for the 600 mg dose (p< 0.0001) using the more rigorous "intent-to-treat" (ITT) analysis and 87 percent using a "last observation carried forward" (LOCF) analysis. As a result, the number of patients taking the combination who achieved the medically recommended target of below 6 mg/dL was more than three times the number of patients who achieved the target on allopurinol alone.

The combination of lesinurad and allopurinol was generally well tolerated in the main 28-day dosing period and has been well tolerated in the ongoing extension period. Adverse events were infrequent, not dose related and comparable between the groups receiving lesinurad and placebo.

Preclinical Data Presented

The Company also presented data from a completed preclinical study evaluating lesinurad's effect on the hyperuricemia caused by the commonly used diuretic, hydrochlorothiazide. Hypertension is prevalent in gout patients and they are often treated with anti-hypertensive agents such as thiazide diuretics.  These agents have for some time been known to reduce uric acid excretion from the kidney, and thus increase sUA levels, which can exacerbate the condition of gout patients. The reduction in uric acid excretion by these agents is believed to be due to activation of a uric acid transporter in the kidney known as OAT4.  Results from a completed preclinical study were presented at EULAR showing that lesinurad is an active inhibitor of the OAT4 transporter. This secondary activity may significantly offset the sUA-increasing effects of thiazide diuretics, thereby achieving a second
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SOURCE Ardea Biosciences, Inc.
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