Apr 01, 2010 (Datamonitor) -- Ardea Biosciences, a biotechnology company, has reported positive, preliminary, topline results from its Phase IIb monotherapy study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout.
In this 28-day, randomized, double-blind, placebo-controlled, dose-escalation study, 123 gout patients with hyperuricemia (serum urate levels greater than or equal to 8mg/dl) 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. All patients received colchicine for prophylaxis against flares. The primary endpoint of the study was a significant increase in the proportion of patients who achieved a response, defined as a reduction of serum urate to lesser than 6mg/dl after four weeks of treatment, compared to placebo, said Ardea.
The primary endpoint was achieved in this study. Reductions in serum urate and response rates increased in a dose-related manner and were clinically and statistically significant at both the 400mg qd and 600mg qd dose levels. At the highest dose, there was a 38% median reduction in serum urate levels after four weeks compared to a 1% increase on placebo (p<0.0001). This translated into a response rate of 45%, compared to 0% for placebo (p<0.0001).
According to the company, this study enrolled patients who, on average, had a higher baseline serum urate level (median 9.8mg/dl) than observed in its previous studies. The response rate at the highest dose in patients with baseline serum urate levels of lesser than 10mg/dl (9.2mg/dl on average) was 58% (p = 0.0012). RDEA594 was well tolerated in this study.
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 IIb 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 III clinical development plans later in 2010.”
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