May 26 2011
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) presented positive data from its two completed, randomized, double-blind, placebo-controlled Phase 2 studies of BCX4208 in patients with gout at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in London, U.K.
BioCryst's two posters report efficacy findings from the Company's Phase 2 study evaluating BCX4208 alone and in combination with allopurinol (Presentation Number THU0011); and pooled safety results from this combination study and the Company's Phase 2 BCX4208 monotherapy study (Presentation Number THU0027). In both these studies, BCX4208 was administered once-daily for 3-weeks in gout patients.
Poster THU0011 titled "BCX4208 Shows Synergistic Reductions in Serum Uric Acid in Gout Patients When Combined with Allopurinol" by A. Hollister et al. additionally concludes that the combination of BCX4208 and allopurinol brought a larger proportion of gout patients to serum uric acid level below 6 mg/dL than allopurinol alone. There were no pharmacokinetic drug-drug interactions between BCX4208 and either allopurinol or its active metabolite, oxypurinol.
Poster THU0027 titled "BCX4208, A Novel Urate-Lowering Therapy, Was Generally Safe and Well Tolerated in Two 3-Week Studies in Gout Patients" by S. Dobo et al. concludes that the adverse event profile was similar in recipients of BCX4208, allopurinol, placebo or both drugs combined; the most common adverse events being diarrhea and headache. The rate of infections was similar between BCX4208 alone and in combination with allopurinol compared to placebo. The combination of BCX4208 and allopurinol did not alter the safety profile compared with either agent administered alone.
"We are encouraged by these results, as they reaffirm our belief that combining BCX4208 with other urate-lowering therapies, such as allopurinol, is a promising path forward for our Phase 3 development program," said Dr. William Sheridan, Senior Vice President & Chief Medical Officer of BioCryst. "Our ongoing Phase 2b study of BXC4208 as add-on therapy in gout patients who have not responded to allopurinol therapy alone is progressing well. We are pleased to report that we have now exceeded target enrollment, and look forward to reporting both full 12-week and partial 6-month data later this year."