The double-blind, dose-response, randomized study enrolled 279 patients to five study arms BCX4208 at doses of 5 mg, 10 mg, 20 mg, 40 mg and placebo, administered once-daily for 12-weeks.
Allopurinol 300 mg once-daily was administered in all study arms.
The primary endpoint of the study, the proportion of patients with sUA <6 mg/dL at day 85, was
acheived.
BCX4208 was superior to allopurinol plus placebo (p=0.009 overall), when added to allopurinol 300 mg.
BioCryst Pharmaceuticals senior vice president & CMO William Sheridan said they expect to report 6-month results from the ongoing extension study in early 2012, which will provide additional insight into BCX4208’s safety and efficacy profile.
"We are on track to conclude this Phase 2 program during the first half of next year and we look forward to discussing the results in more detail with regulatory authorities and potential partners," Sheridan said.