SAN DIEGO, July 9 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. today announced that it has received regulatory approval to begin a Phase 2a proof-of-concept clinical trial evaluating RDEA806 in gout patients with hyperuricemia. Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream, and is the most common form of inflammatory arthritis in men over 40. The Company also announced that gout specialist, Dr. Fernando Perez-Ruiz in Spain, will be the newest member of its inflammatory disease scientific advisory board (SAB).
Ardea previously announced the designation of RDEA594, a major metabolite of RDEA806, the Company’s lead human immunodeficiency virus (HIV) development compound, as its lead development candidate for the treatment of patients with gout. RDEA594 does not have antiviral activity, but is believed to be responsible for essentially all of the uric acid lowering effects seen with RDEA806. Uric acid lowering effects have been observed following administration of RDEA806 in Phase 1 and Phase 2 clinical trials that included over 100 subjects.
“The Phase 2a trial should allow us to confirm RDEA594’s activity in the target population of patients with gout using its prodrug, RDEA806. Enrollment in the Phase 2a trial should begin shortly and we are on track to initiate a Phase 1 trial with RDEA594 in the second half of this year,” said Barry D. Quart, PharmD, Ardea Biosciences’ President and CEO. “We also are extremely pleased to add Dr. Fernando Perez-Ruiz to our inflammatory diseases SAB. Dr. Perez-Ruiz has extensive experience treating gout patients with drugs of the same class as RDEA594.”
The Phase 2a randomized, double-blind, dose ranging, efficacy and safety trial will be conducted in academic medical centers in Europe and Canada. In this trial, we plan to evaluate the serum uric acid (sUA) level, pharmacokinetics, safety and tolerability of two different dose regimens of RDEA806 versus placebo in establishing normal sUA concentrations in gout patients with hyperuricemia (greater than or equal to 8.0 mg/dl). The primary efficacy endpoint is the proportion of subjects whose sUA level is less than 6.0 mg/dl following four weeks of treatment.
Dr. Fernando Perez-Ruiz is an Assistant Head of the Rheumatology Division at the Hospital de Cruces in Vizcaya, Spain. He received his medical degree from the Basque Country University in Bilbao, Spain, and a PhD from Barcelona University, Spain. Board-certified in Rheumatology, Dr. Perez-Ruiz is a member of the American College of Rheumatology and Spanish Society for Rheumatology and has collaborated with the European League Against Rheumatism (EULAR) Task Force for Gout and with the Outcome Measures for Rheumatic Arthritis Clinical Trials (OMERACT) group for chronic gout. He serves on the editorial boards of Arthritis Rheumatism (Care & Research), Bone Joint Spine, and Reumatologia Clinica and serves as a reviewer for more than 20 international journals. His research interests include crystal-induced arthritis, especially gout, but he has also investigated lupus, rheumatoid arthritis and fibromyalgia. Dr. Perez-Ruiz has published more than 80 articles on topics related to rheumatology, and most frequently to hyperuricemia and gout.
About Gout
An estimated 3-5 million people in the United States 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 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, cancer and inflammatory diseases, including gout. We have four drug candidates in clinical trials and others in preclinical development and discovery. Our most advanced development candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (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 as a development candidate based on its long plasma half-life. RDEA594, our lead development candidate for the treatment of gout, is in preclinical development 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 study in advanced cancer patients, as well as in 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 as a development candidate.
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.
CONTACT: Investors, John Beck of Ardea Biosciences, +1-858-652-6523,
jbeck@ardeabio.com; or Media, Edie DeVine of WeissComm Partners,
+1-415-946-1081, edevine@wcpglobal.com, for Ardea Biosciences, Inc.
