San Diego-based Ardea Biosciences has unveiled promising Phase II results from a trial of its oral gout drug RDEA594. When combined with the standard treatment allopurinol, 89 percent of patients experienced a statistically significant reduction in serum uric acid, the build-up of which causes pain in the joints. Only 30 percent to 40 percent of gout patients respond adequately to allopurinol alone. The only serious adverse event in the study, a fatal myocardial infarction, occurred in a patient taking only allopurinol. No serious adverse events or deaths occurred while patients were on RDEA594.
"The encouraging safety and efficacy results from this multi-center, randomized study of RDEA594 in combination with allopurinol provide a strong basis to advance this innovative product into Phase III clinical development," said John Sundy, associate professor of medicine and director of the Duke Clinical Research Unit. The company's next step is a meeting with the FDA regarding its Phase III plans. Full results will be presented at an upcoming conference.
After decades of stasis, developers have recently made progress on new treatments for gout, a disease that affects an estimated 5 million people in the U.S. alone. In 2009, Takeda won FDA approval for Uloric--the first new gout drug in 40 years. And last year Savient Pharmaceuticals gained approval for its treatment Krystexxa.
- here's Ardea's release