August 21, 2008
Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial
SAN DIEGO, Aug. 21 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. 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.
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
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.
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(R)) 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(R) (emtricitabine and tenofovir) from Gilead Sciences, Inc, which is important for patient compliance.
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, gout, cancer and inflammatory diseases. We have five product candidates in clinical trials and others in preclinical development and discovery. Our most advanced product candidate is RDEA806, an NNRTI, which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of gout, is being evaluated in a Phase 1 study. We are currently evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients, and have completed a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it for clinical development.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the results of preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, and costs associated with our drug discovery and development programs and business development activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Ardea Biosciences, Inc.
CONTACT: Investors, John Beck of Ardea Biosciences, Inc.,+1-858-652-6523, [email protected]; or Media, Edie DeVine of WeissCommPartners, +1-415-946-1081, [email protected], for Ardea Biosciences, Inc.