RDEA684 Is Selected as Next-Generation Development Candidate for
Treatment of Gout
Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced that it has
initiated a Phase 2b clinical trial of RDEA594, its lead product
candidate in development for the management of hyperuricemia and gout.
The Company also announced the selection of RDEA684, a next-generation
URAT1 inhibitor, as a development candidate for the same indication.
The randomized, double-blind, placebo-controlled, dose-response study
will evaluate the safety and serum urate-lowering effects of 200, 400
and 600 mg of RDEA594 in a total of 140 gout patients with hyperuricemia
(uric acid levels of 8 mg/dL or more). The primary efficacy endpoint is
the proportion of patients whose serum urate level is less than 6.0
mg/dL following four weeks of treatment. This study will be conducted at
multiple sites in Europe and North America, with initial results
expected by the end of 2009. The remaining studies in the planned Phase
2 program, including a Phase 2 study evaluating RDEA594 as an add-on to
allopurinol in patients not responding adequately to allopurinol alone,
a drug-drug interaction study with febuxostat (Uloric®,
Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen), and
a study in patients with renal impairment, are expected to begin shortly.
“Our Phase 2 program is designed to demonstrate RDEA594’s broad clinical
potential in a wide spectrum of gout patients, including first-line use
and as add-on therapy in patients not achieving an adequate response to
either allopurinol or febuxostat, and in patients with varying degrees
of renal impairment,” commented Barry D. Quart, Pharm.D., Ardea’s
president and chief executive officer. “The FDA approval of febuxostat
earlier this year and the recent recommendation by the FDA’s Arthritis
Advisory Committee for approval of pegloticase (Krystexxa™, Savient
Pharmaceuticals) for treatment-refractory gout has demonstrated the
importance of new urate-lowering therapies for treatment of patients
suffering from gout.”
About RDEA594 and RDEA684
RDEA594, our lead product candidate for the treatment of hyperuricemia
and gout, is a selective URAT1 transporter inhibitor that has
successfully completed a Phase 2a proof-of-concept study in gout
patients with hyperuricemia, as well as single- and
multiple-ascending-dose Phase 1 studies in normal, healthy volunteers.
Over 300 people have safely received RDEA594, either by direct
administration or through administration of RDEA806, its prodrug.
