R3421: Extension study data

Data from 160 patients in the double-blind, 6-month safety extension of the Phase IIb Study 203 showed oral BCX4208 plus allopurinol was safe and well-tolerated. The types and rates of adverse events through 6 months were similar between patients receiving BCX4208 plus allopurinol vs. placebo plus allopurinol, with no opportunistic or unusual infections observed. Gout flares occurred more frequently in patients receiving BCX4208 vs. placebo (7-16% vs. 5%). Response rates for subjects receiving 5, 10, 20 and 40 mg BCX4208 were higher compared with placebo at week 24 (40%, 50%, 46% and 55%, respectively, vs. 25%). BioCryst selected the 4, 10 and 20 mg doses for further evaluation. The company is preparing for end of Phase II discussions with FDA "in the coming months." ...