BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) announced the initiation of a Phase 2b study of BCX4208 as add-on therapy in gout patients who have not responded to allopurinol therapy alone.

“We anticipate completing this study and reporting top-line data towards the end of 2011.”

This randomized, double-blind, dose-response 250-patient study is designed to evaluate the safety and efficacy of BCX4208 in combination with allopurinol in gout patients who have failed to reach the serum uric acid (sUA) objective of <6 mg/dL following treatment with allopurinol 300 mg alone. The primary endpoint of the study is the proportion of subjects with sUA <6 mg/dL at day 85. The study utilizes a parallel-group design, evaluating BCX4208 at doses of 5 mg, 10 mg, 20 mg, 40 mg and placebo administered once-daily for 12 weeks, in combination with allopurinol's standard dose of 300 mg. BCX4208 doses of 20 mg per day up to 240 mg per day have been found to be generally safe and well-tolerated in more than 180 patients in short-term studies. Further details regarding this study design will be available on clinicaltrials.gov.

"We are very pleased with the clinical results generated to date, and excited to now study the efficacy and safety of 12 weeks of BCX4208 added to allopurinol in patients suffering with gout. Based on our most recent trial, we anticipate seeing clinically important reductions in serum uric acid concentrations when low doses of BCX4208 are added to the allopurinol treatment regimen," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "We anticipate completing this study and reporting top-line data towards the end of 2011."