Health & Fitness
Health and Fitness
Health and Fitness
Tue, June 1, 2010 BioCryst Initiates a Phase 2 Study of BCX4208 Alone and in Combination with Allopurinol in Patients with Gout
BIRMINGHAM, Ala.--([ BUSINESS WIRE ])--BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today 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 ]
aWe 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,a said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. aWe expect to complete this study during 2010 and look forward to providing top-line data in the fourth quarter.a
About BCX4208
BCX4208 is a next generation purine nucleoside phosphorylase (PNP) inhibitor with the potential for once-a-day dosing suitable for chronic administration. Previous studies have shown that BCX4208 may have utility in diseases dependent on T-cells, B-cells or uric acid. With its novel mechanism of action, BCX4208 has the potential to address unmet medical needs across a broad spectrum of inflammatory diseases, including gout.
About Gout
Gout is an inflammatory arthritis that affects up to five million people in the U.S. Gout is caused by higher-than-normal uric acid in the blood, (a condition known as hyperuricemia) that may lead to the buildup of uric acid in synovial fluid around joints and the formation of monosodium urate crystals that result in painful joint inflammation. More information regarding gout and hyperuricemia is available at: [ http://www.cdc.gov/arthritis/basics/gout.htm ]
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds that are in late-stage pivotal clinical trials; [ peramivir ], an anti-viral for influenza, and [ forodesine ], a purine nucleoside phosphorylase (PNP) inhibitor forcutaneous T-cell lymphoma (CTCL). Additionally, BioCryst has a third product candidate, BCX4208a"a next generation PNP inhibitora"in mid-stage trials for the treatment of gout. 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 Web site at [ www.biocryst.com ].
Forward-Looking Statements
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 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 our product candidates may not receive required regulatory clearances from the FDA; that ongoing and future preclinical or clinical development and commercialization of our product candidates, including peramivir, forodesine, BCX4208 and other PNP inhibitor and hepatitis C development programs, 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 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.
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