Ardea Biosciences, Inc. announced that it has completed formal end-of-phase II meetings with the US Food and Drug Administration (FDA) and successfully reached agreement on the following key aspects of its proposed lesinurad phase III development plan: the overall size and design of the planned phase III 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 programme and the clinical pharmacology programme. The Company continues to target commencing phase III 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 Michael Becker, MD, Professor Emeritus of Medicine, Department of Medicine, University of Chicago Medical Centre. “The encouraging safety and efficacy results from phase II clinical trials of lesinurad provide strong support for successful phase III clinical development.”

In connection with the Company's phase III development programme 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 III 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 III study of lesinurad monotherapy for patients in whom allopurinol is contraindicated. A phase III study of lesinurad in combination with febuxostat is also planned.

“We are very gratified with the positive outcome and clear feedback from the FDA at our end-of-phase II meetings," commented Barry D Quart, Pharm D, Ardea's president and chief executive officer. “We were also very pleased to have recently initiated our allopurinol interventional trial, as it is an important first step in the efficient and effective conduct of our overall phase III programme for lesinurad. It should help expedite overall enrollment in the main portion of our phase III programme by enabling us to identify ahead of time eligible patients to participate in our studies.”

Gout is a painful, debilitating and progressive disease caused by abnormally elevated levels of uric acid in the blood stream. This leads to the deposition of painful, needle-like uric acid crystals in and around the connective tissue of the joints and in the kidneys, resulting in inflammation, the formation of disfiguring nodules, intermittent attacks of severe pain and kidney damage. In addition, evidence suggests that the chronic elevation of uric acid associated with gout, known as hyperuricemia, may also have systemic consequences, including an increased risk for kidney dysfunction and cardiovascular disease.

In 2008, approximately 8.3 million patients in the US, 9 million patients in the European Union and 2.9 million patients in Japan had been diagnosed with gout. Gout is the most common form of inflammatory arthritis in men over the age of 40 and represents a significant unmet medical need with limited treatment options.

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. It 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 I and II clinical trials.

Ardea Biosciences, Inc., a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.