BioCryst Announces Positive Results from Two Ulodesine Phase 2 Trials in Patients with Gout

BioCryst Pharmaceuticals, Inc.

today announced favorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase 2b trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase 2 safety results in patients with mild to moderate renal impairment. In the original 12-week study, 279 patients were randomized. The extension to 52 weeks, in which 119 patients entered the final extension phase, concludes the Phase 2b trial and Phase 2 development program for ulodesine. Patients continued their blinded, randomized therapy of ulodesine at doses of 5 mg, 10 mg and 20 mg and placebo once-daily. Allopurinol 300 mg once-daily was administered in all study arms.