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news.Ardea Biosciences has reported encouraging preliminary data from an ongoing Phase I trial of RDEA594, its lead product candidate in development for the treatment of hyperuricemia and gout.
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Preliminary data from a Phase I single ascending dose study of RDEA594 in healthy volunteers showed that oral administration of 100mg of RDEA594 demonstrated a favorable pharmacokinetic profile with low systemic clearance, favorable absorption and a half-life supporting once-daily dosing.
Additionally, 100mg of RDEA594 produced a significant increase in urinary excretion of uric acid, confirming that RDEA594 is responsible for the uric acid-lowering effects observed in previous clinical studies of RDEA806, the company’s lead non-nucleoside reverse transcriptase inhibitor in development for the treatment of HIV, said Ardea.
Barry Quart, president and CEO of Ardea, said: “These encouraging preliminary data confirm our selection of RDEA594 as our lead product candidate for the treatment of hyperuricemia and gout. We are working towards rapidly completing the Phase I program evaluating the safety and uric acid-lowering effects of RDEA594 with higher single doses and multiple daily dosing to allow us to enter Phase II early next year.”