SAN DIEGO, Aug. 21 Ardea Biosciences, Inc.(Nasdaq: RDEA) today announced that the Medicines and Healthcare productsRegulatory Agency (MHRA) in the United Kingdom has authorized a Phase 1 studyevaluating RDEA594 in normal healthy volunteers. RDEA594 is the Company'slead 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 tothe efficiency of our development organization, and the importance we place onour gout program -- a program we intend to expand with second-generationcompounds 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 ofRDEA594, which should allow us to provide an early confirmation of RDEA594'sactivity in the target population of patients with gout."
This Phase 1, randomized, double-blind, placebo-controlled trial willevaluate the safety, tolerability, pharmacokinetics and uric acid loweringeffects of single ascending oral doses of RDEA594 in healthy adult malevolunteers.
An estimated 3-5 million people in the United States, and approximately 5million people in the European Union, suffer from gout, which is the mostcommon form of inflammatory arthritis in men over 40. Gout, also known asmetabolic arthritis, is a painful and debilitating disease caused byabnormally elevated levels of uric acid in the blood stream. These abnormallyelevated levels lead to the deposition of uric acid crystals in and around theconnective tissue of the joints and in the kidneys, leading to inflammation,the formation of disfiguring nodules (tophi), intermittent attacks of severepain (acute flares), and kidney damage (nephropathy). While gout is atreatable condition, there are limited treatment options and a number ofadverse effects are associated with current therapies. No new therapies havebeen approved by the FDA for the treatment of hyperuricemia associated withgout in the past 40 years
RDEA594, our lead product candidate for the treatment of gout, is a majormetabolite of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor(NNRTI) in clinical development for the treatment of HIV. RDEA594 does nothave antiviral activity and is believed to be responsible for the uricacid-lowering effects observed following administration of RDEA806 to over 100subjects in Phase 1 and Phase 2 clinical trials. In Phase 1 studies ofRDEA806 in normal healthy volunteers, increased urinary excretion of uric acidwas observed in the first 24 hours after dosing, with statisticallysignificant, exposure-dependent, decreases in serum uric acid of 35% to 50%observed during multiple dosing out to 14 days.
RDEA806 is a novel NNRTI for the potential treatment of HIV infection.Based on preclinical and clinical studies to date, we believe that RDEA806 mayhave important competitive advantages compared to currently available NNRTIs.These include the potential for potent antiviral activity against a wide rangeof HIV viral isolates, including those that are resistant to efavirenz(Sustiva(R)) and other currently available NNRTIs; a high genetic barrier toresistance; limited pharmacokinetic interactions with other drugs; noreproductive toxicity based on animal studies; and the potential to be readilyco-formulated in a single pill with other HIV antiviral drugs, such asTruvada(R) (emtricitabine and tenofovir) from Gilead Sciences, Inc, which isimportant for patient compliance.
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a biotechnologycompany focused on the discovery and development of small-moleculetherapeutics for the treatment of HIV, gout, ca