Shares of BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX ) are up slightly in early trading after the company 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.
BCX4208 is a novel enzyme inhibitor with the potential for once-a-day oral dosing suitable for chronic administration.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.
“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.”
BioCryst’s two posters presented reported efficacy findings from the Company’s Phase 2 study evaluating BCX4208 alone and in combination with allopurinol.
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.
The EULAR posters are available on BioCryst’s website at http://investor.shareholder.com/biocryst/events.cfm. in addition, BioCryst will host a conference call and webcast today at 6 p.m. GMT (1 p.m. ET) to provide further details on the data from these two studies as well as provide a clinical overview and update for the BCX4208 program.
To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto BioCryst’s website.
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