Sept. 7, 2011
/PRNewswire/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and successfully reached agreement on the following key aspects of its proposed lesinurad Phase 3 development plan: the overall size and design of the planned Phase 3 clinical studies, the primary endpoints, the total safety database proposed for NDA filing, manufacturing plans for both drug substance and drug product, the preclinical toxicology program and the clinical pharmacology program. The Company continues to target commencing Phase 3 studies before the end of this year. Lesinurad is Ardea's lead product candidate in development for the chronic treatment of gout.
"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," commented
, MD, Professor Emeritus of Medicine, Department of Medicine,
University of Chicago
Medical Center. "The encouraging safety and efficacy results from Phase 2 clinical trials of lesinurad provide strong support for successful Phase 3 clinical development."
In connection with the Company's Phase 3 development program and as previously announced, the Company recently commenced a multinational, interventional study designed to identify gout patients not reaching target serum uric acid (sUA) levels on allopurinol, currently the most widely prescribed gout medication. In addition to collecting clinically relevant information on the use of allopurinol, this study will also assist in pre-screening and determining the eligibility of gout patients to enroll into two pivotal Phase 3 studies, which will evaluate the effect of adding lesinurad to allopurinol in patients who do not reach target sUA levels on allopurinol alone. The interventional study will also help identify allopurinol-intolerant patients who would be eligible for the Company's Phase 3 study of lesinurad monotherapy for patients in whom allopurinol is contraindicated. A Phase 3 study of lesinurad in combination with febuxostat is also planned.