BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today 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 presented today 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."

About BCX4208

BCX4208 is a novel enzyme inhibitor with the potential for once-a-day oral dosing suitable for chronic administration. It acts upstream of xanthine and hypoxanthine in the purine metabolic pathway to reduce serum uric acid (sUA) in patients with gout and has a mechanism of action that complements xanthine oxidase inhibitors, such as allopurinol and febuxostat, in reducing uric acid production. With its unique mechanism of action, clinical activity and safety in clinical studies to date, as well as its potential synergy with approved therapies, BCX4208 may address unmet medical needs across a broad spectrum of inflammatory and autoimmune diseases.

Completed and Ongoing BCX4208 Gout Studies

The Phase 2 monotherapy study BCX4208-201 was a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral daily doses of 40, 80, 120, 160 or 240 mg administered for 21-days to patients with gout. The Phase 2 combination study BCX4208-202 was a randomized, double-blind, multi-center, placebo-controlled study designed to evaluate the urate-lowering activity and safety of daily doses of placebo or 20, 40 or 80 mg of BCX4208 when studied alone or in combination with placebo or 100, 200 or 300 mg of allopurinol administered once-daily. The ongoing Phase 2b study BCX4208-203 is a randomized, double-blind, 250-patient dose-response study designed to evaluate the safety and efficacy of placebo or 5, 10, 20 or 40 mg of BCX4208 in combination with 300 mg allopurinol in gout patients who have failed to reach the serum uric acid objective of <6 mg/dL following treatment with allopurinol alone.

Source:
BioCryst Pharmaceuticals