Ardea Biosciences Presents Preliminary Data from a Phase 1 Study of RDEA594 at the 2008 ACR/ARHP Annual Scientific Meeting
SAN DIEGO--(BUSINESS WIRE)--Oct 27, 2008 - Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that preliminary data were presented from an ongoing Phase 1 trial of RDEA594, its lead product candidate in development for the treatment of hyperuricemia and gout, at the 2008 American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in San Francisco, California.
Preliminary data from a Phase 1 single ascending dose study of RDEA594 in healthy volunteers show that oral administration of 100 mg of RDEA594 demonstrated a favorable pharmacokinetic profile with low systemic clearance, favorable absorption and a half-life supporting once-daily dosing. Additionally, 100 mg of RDEA594 produced a significant increase in urinary excretion of uric acid, confirming that RDEA594 is responsible for the uric acid-lowering effects observed in previous clinical studies of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in development for the treatment of HIV.
"These encouraging preliminary data confirm our selection of RDEA594 as our lead product candidate for the treatment of hyperuricemia and gout," commented Barry D. Quart, PharmD, president and chief executive officer. "Gout is a major medical condition affecting millions of patients worldwide and there is mounting evidence for an association between elevated uric acid and the risk of cardiovascular and renal diseases in patients with undiagnosed hyperuricemia and gout. We are working towards rapidly completing the Phase 1 program evaluating the safety and uric acid lowering effects of RDEA594 with higher single doses and multiple daily dosing to allow us to enter Phase 2 early next year."
RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, currently in Phase 1 clinical development, is a major metabolite of RDEA806, our lead NNRTI in clinical development for the treatment of HIV. RDEA594 does not have antiviral activity and is responsible for the uric acid-lowering effects observed following administration of RDEA806 to over 150 subjects in Phase 1 and Phase 2 clinical trials.
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 and is entering Phase 2b. 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 hyperuricemia and gout, is being evaluated in a Phase 1 clinical trial and is believed to be an inhibitor of the URAT1 transporter in the kidney, which is responsible for regulation of uric acid levels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1/2 study in combination with sorafenib (Nexavar(R), Onyx Pharmaceuticals, Bayer HealthCare) and as a single agent in a Phase 1 study, both 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 plans and goals, the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds, and the timing and results of our 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, costs associated with our drug discovery and development programs, and risks related to the outcome of our 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.
Posted: October 2008