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news.Ardea Biosciences, a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and HIV, has reported positive, preliminary, top-line results from its Phase 2b monotherapy study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout.
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Ardea Biosciences said that in the 28-day, randomised, double-blind, placebo-controlled, dose-escalation study, 123 gout patients with hyperuricemia, received 200mg once-daily (qd) RDEA594, 400mg qd RDEA594, 600mg qd RDEA594 or matching placebo. For patients receiving 400mg qd RDEA594 and 600mg qd RDEA594, their dose was titrated up weekly in increments of 200mg/day.
The study specifically enrolled patients who excrete less than normal amounts of uric acid at baseline (under-excretors of uric acid make up approximately 90% of all gout patients). All patients received colchicine for prophylaxis against flares.
The study results suggested that the primary endpoint was achieved. Reductions in serum urate and response rates increased in a dose-related manner and were highly clinically and statistically significant at both the 400mg qd and 600mg qd dose levels.
Additionally, at the highest dose, there was a 38% median reduction in serum urate levels after 4 weeks compared to a 1% increase on placebo. This translated into a response rate of 45%, compared to 0% for placebo.
John Sundy, associate professor of medicine and head of the section of allergy and clinical immunology in the division of pulmonary of allergy and critical care medicine at Duke University Medical Center, said: “The encouraging safety and efficacy results from this multi-center, randomised study of RDEA594 provide a strong basis to advance this innovative product into Phase 3 clinical development.
“There is a major unmet medical need for a well-tolerated, orally administered urate-lowering therapy that works by a novel mechanism of action and can be given alone or in combination with other agents to the many patients who are not adequately treated with currently available products.”
Barry Quart, president and CEO of Ardea Biosciences, said: “We are obviously very pleased with these results and also look forward to the results of our Phase 2b allopurinol combination study, which we believe will complement these findings. We plan to report the combination study results in the second quarter of this year and to meet with regulatory authorities to discuss our Phase 3 clinical development plans later this year. We also hope to present the full details of both Phase 2b studies at the next appropriate scientific conference.”