SAN DIEGO, Dec. 1 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. today announced positive results from the first dosing group of an ongoing drug-drug interaction and pharmacodynamic study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, and febuxostat (Uloric(R), Takeda Pharmaceutical Company Limited; Adenuric(R), Ipsen). This randomized, placebo-controlled study in normal healthy volunteers with baseline serum urate levels of greater than 5 mg/dL is designed to evaluate the potential for pharmacokinetic drug interactions, as well as the serum urate-lowering effect, safety and tolerability of escalating doses of RDEA594, administered once-daily (QD) in combination with 40 mg febuxostat.
“The substantial reduction in serum uric acid observed when RDEA594 and febuxostat are co-administered indicate that these two oral agents with complementary mechanisms may be able to accelerate improvement in tophaceous gout compared to single agent therapy,” commented John S. Sundy MD, PhD, associate professor of medicine and head of the Section of Allergy and Clinical Immunology in the Division of Pulmonary, Allergy and Critical Care Medicine at Duke University Medical Center and a member of Ardea’s scientific advisory board. “I look forward to studying this combination in patients with advanced disease.”
In addition to this study, RDEA594 is currently being administered in a Phase 2b single-agent dose-response study evaluating the safety and urate-lowering effects of 200, 400 and 600 mg of RDEA594, a Phase 2b study evaluating RDEA594 as an add-on to allopurinol in patients that do not respond adequately to allopurinol alone, and a study in gout patients with renal impairment.
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV). RDEA594, our lead product candidate in development for the treatment of hyperuricemia and gout, is a selective URAT1 transporter inhibitor in Phase 2 clinical development. Our next-generation URAT1 inhibitor, RDEA684, is currently in preclinical development. RDEA119, a potent and specific inhibitor of mitogen-activated ERK kinase (MEK), is being developed under a global license agreement with Bayer HealthCare. RDEA119 is being evaluated as a single agent in a Phase 1 study in advanced cancer patients and in a Phase 1/2 study in combination with sorafenib (Nexavar(R); Bayer HealthCare, Onyx Pharmaceuticals) in advanced cancer patients. RDEA806, for the treatment of HIV, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that has successfully completed a Phase 2a study in HIV patients. RDEA427, a next generation NNRTI, has superior pharmacokinetic properties, and even greater activity against a wide range of drug-resistant viral isolates than RDEA806. We have evaluated RDEA427 in a human micro-dose pharmacokinetic study.
(Logo: http://www.newscom.com/cgi-bin/prnh/20091104/ARDEALOGO)
Photo: http://www.newscom.com/cgi-bin/prnh/20091104/ARDEALOGO
http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.comArdea Biosciences, Inc.
