BioCryst to commence Phase 2 study of BCX4208 alone and in combination with allopurinol in gout patients

Jun 1 2010

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) announced it is initiating a Phase 2 study of BCX4208 alone and in combination with allopurinol in patients with gout. BioCryst recently reported positive results from part one of its Phase 2 monotherapy study of BCX4208 in patients with gout and is now moving forward as planned with an additional Phase 2 trial of BCX4208.

“We expect to complete this study during 2010 and look forward to providing top-line data in the fourth quarter.”

This randomized, double-blind, multi-center, placebo-controlled study is designed to evaluate the urate-lowering activity and safety of several doses of BCX4208 alone and in combination with selected doses of allopurinol administered once-daily in patients with gout for 21 days. The enrollment target for this study is approximately 80 patients. The study utilizes a factorial design, evaluating BCX4208 at doses of 20 mg, 40 mg and 80 mg administered as monotherapy or in combination with allopurinol at doses of 100 mg, 200 mg and 300 mg. Allopurinol administered at 300 mg is the most common treatment dose for patients with gout. The doses of BCX4208 selected for this study have been found to be generally safe and well-tolerated in patients with psoriasis or gout. Further details regarding this Phase 2 study design is available at clinicaltrials.gov at the following link: http://clinicaltrials.gov/ct2/show/NCT01129648

"We are pleased to initiate this Phase 2 study of BCX4208, a highly potent and selective PNP inhibitor, as it will help to determine whether the inhibition of xanthine oxidase and PNP together has additive or synergistic effects in reducing uric acid levels in patients with gout," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "We expect to complete this study during 2010 and look forward to providing top-line data in the fourth quarter."