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- Ongoing BCX4208 Phase 2b add-on study exceeds enrollment target
BioCryst will host a conference call & webcast today at
6 p.m. GMT( 1 p.m. ET) RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- 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 Rheumatologyhosted 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.
Hollisteret 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."
The EULAR posters are available on BioCryst's website at http://investor.shareholder.com/biocryst/events.cfm.
Conference Call and Webcast
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. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.
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. To learn more about this ongoing study visit http://clinicaltrials.gov/ct2/show/NCT01265264.
BioCryst Pharmaceuticalsdesigns, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, inflammatory diseases and cancer. BioCryst currently has three novel late-stage compounds in development: peramivir, a neuraminidase inhibitor for the treatment of influenza, BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout, and forodesine, an orally-available PNP inhibitor for hematological malignancies. Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. For more information, please visit the Company's website at www.biocryst.com.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that there can be no assurance that our compounds will prove effective in clinical studies; that development and commercialization of our compounds may not be successful; that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed; that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates; that our product candidates may not receive required regulatory clearances from the
FDA; that ongoing and future pre-clinical and clinical development may not have positive results; that we or our licensees may not be able to continue future development of our current and future development programs; that our development programs may never result in future product, license or royalty payments being received by BioCryst; that BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or it may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of its product candidates; that our actual cash burn rate may not be consistent with our expectations; that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in our projections and forward-looking statements.
BioCryst Pharmaceuticals Robert Bennett, 919-859-7910 (investors)
Carolyn Wang, 415-946-1065 (media)
BioCryst Pharmaceuticals, Inc.
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