R&D In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Positive results for Ardea Biosciences' hyperuricemia and gout therapy: Ardea Biosciences releases positive results of its proof-of-concept trial for its hyperuricemia and gout therapy RDEA594. In the Phase IIa study, a combination of the drug and allopurinol reduced serum urate rate levels an additional 24 percent compared to allopurinol alone. After one week on allopurinol alone, 50 percent of patients qualified as responders, and serum urate levels were reduced by 39 percent. Adding 200 mg RDEA594 for an additional week produced a 48 percent reduction in serum levels, and increasing the dose to 400 mg resulted in a 54 percent reduction. Ardea said no unusual side effects or safety issues have been reported. The sponsor also received positive results from the second panel of a Phase I drug-drug interaction pharmacodynamic study of RDEA594 in combination with febuxostat, in which 400 mg of the investigational drug produced a 49 percent decrease in serum levels and 40 mg dose of febuxostat resulted in a 45 percent decrease. However, a combination of the two resulted in approximately 70 percent mean reduction in serum levels compared to baseline