Ardea Biosciences, Inc. (RDEA)

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Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial
Thursday August 21, 8:00 am ET

SAN DIEGO, Aug. 21 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has authorized a Phase 1 study evaluating RDEA594 in normal healthy volunteers. RDEA594 is the Company's lead product candidate for the treatment of gout.

"Regulatory clearance for us to proceed with our Phase 1 study of RDEA594, within six months from designation as a clinical candidate is a testament to the efficiency of our development organization, and the importance we place on our gout program -- a program we intend to expand with second-generation compounds from our exciting ongoing research in this area," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "Earlier this quarter, we initiated a Phase 2a proof-of-concept study of RDEA806, a prodrug of RDEA594, which should allow us to provide an early confirmation of RDEA594's activity in the target population of patients with gout."

This Phase 1, randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, pharmacokinetics and uric acid lowering effects of single ascending oral doses of RDEA594 in healthy adult male volunteers.

About Gout

An estimated 3-5 million people in the United States, and approximately 5 million people in the European Union, suffer from gout, which is the most common form of inflammatory arthritis in men over 40. Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. These abnormally elevated levels lead to the deposition of uric acid crystals in and around the connective tissue of the joints and in the kidneys, leading to inflammation, the formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares), and kidney damage (nephropathy). While gout is a treatable condition, there are limited treatment options and a number of adverse effects are associated with current therapies. No new therapies have been approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years

About RDEA594

RDEA594, our lead product candidate for the treatment of gout, is a major metabolite of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in clinical development for the treatment of HIV. RDEA594 does not have antiviral activity and is believed to be responsible for the uric acid-lowering effects observed following administration of RDEA806 to over 100 subjects in Phase 1 and Phase 2 clinical trials. In Phase 1 studies of RDEA806 in normal healthy volunteers, increased urinary excretion of uric acid was observed in the first 24 hours after dosing, with statistically significant, exposure-dependent, decreases in serum uric acid of 35% to 50% observed during multiple dosing out to 14 days.

About RDEA806

RDEA806 is a novel NNRTI for the potential treatment of HIV infection. Based on preclinical and clinical studies to date, we believe that RDEA806 may have important competitive advantages compared to currently available NNRTIs. These include the potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz (Sustiva®) and other currently available NNRTIs; a high genetic barrier to resistance; limited pharmacokinetic interactions with other drugs; no reproductive toxicity based on animal studies; and the potential to be readily co-formulated in a single pill with other HIV antiviral drugs, such as Truvada® (emtricitabine and tenofovir) from Gilead Sciences, Inc, which is important for patient compliance.