Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Jun 18 2010

Ardea Biosciences, Inc. (Nasdaq: RDEA) announced that additional positive data from its Phase 2 program for RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, are being presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Rome, Italy.  RDEA594, a first-in-class selective inhibitor of the URAT1 transporter, treats the underlying cause of gout by increasing the excretion of uric acid in order to bring the body's levels of uric acid into a normal range.

Highlights of the new data being presented at EULAR include:

• Updated results from a Phase 2b monotherapy study of RDEA594 in 123 gout patients demonstrating a 60% response rate at the highest dose tested.
• Interim results from an ongoing Phase 1b study examining the pharmacokinetics and pharmacodynamics of RDEA594 and allopurinol separately and in combination that demonstrate a 100% response rate in patients receiving two different doses of RDEA594 combined with allopurinol.
• Results from multiple studies indicating that the efficacy of RDEA594 is not diminished in patients with mild-to-moderate renal impairment.
• Safety results from five clinical studies indicating that RDEA594 is well tolerated alone or in combination with allopurinol or febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen and Menarini), with no occurrence of drug-related serious adverse events or dose-related side effects.

"We are pleased to see the very strong and consistent efficacy data from these studies," said Barry D. Quart, PharmD, President and Chief Executive Officer of Ardea Biosciences.  "The interim results from our ongoing Phase 1b study of RDEA594 in combination with allopurinol and our completed proof-of-concept study with febuxostat indicate we can achieve up to 80% mean reductions of uric acid levels when combined with currently marketed agents for the treatment of gout.  These combinations would be among the most potent uric acid lowering treatments available."

"RDEA594 has demonstrated a very consistent efficacy and safety profile," stated Dr. Fernando Perez-Ruiz, Assistant Head of the Rheumatology Division, Hospital de Cruces, Vizcaya, Spain.  "New data from the studies presented at EULAR not only position the drug for Phase 3 studies, but further demonstrate RDEA594's potential to be an important new therapy to treat the millions of gout patients who are currently untreated or under-treated and continue to experience painful and debilitating flares due to the inadequate hypouricemic effect of approved therapies."