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Ardea Biosciences Announces Positive End-of-Phase 2 Meetings with FDA for Lesinurad
Date:9/7/2011

eed with limited treatment options.

About Lesinurad

Lesinurad is our most advanced product candidate for the chronic treatment of gout.  Lesinurad is an oral, once-daily inhibitor of URAT1, a transporter in the kidney that regulates uric acid excretion from the body.  Approximately 90 percent of gout patients are considered to be under-excretors of uric acid, and recent studies have shown that defects in renal transporters have been genetically linked to gout.  Consequently, increasing renal excretion of uric acid by moderating URAT1 transporter activity may provide the most physiologically appropriate means of reducing sUA levels.  In addition, because increasing the excretion of uric acid is additive to the effects of drugs known as xanthine oxidase inhibitors that decrease the production of uric acid, including allopurinol and febuxostat, lesinurad in combination with such drugs has the potential to treat the significant portion of the gout population that is not adequately treated with existing therapies.

Lesinurad has been evaluated as a single agent and in combination with the approved xanthine oxidase inhibitors, allopurinol and febuxostat.  Over 500 people have received lesinurad in Phase 1 and 2 clinical trials.

About Ardea Biosciences, Inc.

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Lesinurad, our lead product candidate for the chronic treatment of gout, is a once-daily, oral inhibitor of the URAT1 transporter.  We have completed Phase 2b clinical studies of lesinurad and continue to advance the drug in longer term extensions of these studies.  In support of our Phase 3 program we are currently advancing lesinurad in a multinational interventional study designed to identify gout patients who can then enroll into our main Phase 3 studies. 
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