BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that it is initiating a Phase 2 study of BCX4208 for the treatment of gout. The primary objective of BioCryst's Phase 2 study is to determine the effect of different doses of orally administered BCX4208 on serum uric acid levels in patients with gout. The gout trial is expected to enroll up to 120 subjects.

"Over the last few decades gout has markedly increased in incidence and prevalence, both in the U.S. and elsewhere. This includes a greater number of difficult cases of chronic or frequently recurrent gout in patients who are intolerant or refractory to the currently approved uric acid lowering drugs," stated Robert Terkeltaub, M.D., VA Rheumatology Section Chief, San Diego Professor of Medicine. "The longstanding unmet need for innovative therapies to reduce hyperuricemia is now being addressed by novel agents, among them BCX4208, that act as novel therapeutics affecting uric acid formation or elimination."

Additionally, Michael A. Becker, M.D., Professor of Medicine Emeritus at The University of Chicago said, "Marked urate lowering effects have been observed in studies in healthy subjects administered BCX4208, achieved by a mechanism unlike that of any currently available gout treatment. This clinical trial of BCX4208 is important for the five million Americans suffering with this disease who need alternatives to current therapies for gout."

The study is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of BCX4208 in subjects with gout. The study's primary endpoint is the change in uric acid in the blood compared to baseline measurement prior to treatment. In a previous study of BCX4208 in patients with psoriasis, patients were administered daily doses up to 120 mg for 6 weeks. Results showed that BCX4208 was safe and well tolerated up to the maximum dose studied, and produced a statistically significant reduction in uric acid concentration in patients.

"BioCryst is pleased to be able to progress the clinical development of BCX4208, a novel and potent PNP inhibitor, with this Phase 2 clinical trial in gout. We expect that the study will define dosing suitable for further development and research in this new indication," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "This is an important step in our strategy to broaden the utility of our PNP inhibitors and to deliver a new treatment option to patients with this disease."

About BCX4208

BCX4208 is a next generation purine nucleoside phosphorylase (PNP) inhibitor with the potential for once-a day dosing suitable for chronic administration. A recent study has 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.

About Gout

Gout is an inflammatory arthritis characterized by the presence of monosodium urate crystals in synovial fluid leukocytes and is always associated with hyperuricemia, or excessive concentrations of uric acid in the blood, during the course of the diseases. Monosodium urate crystals and crystal aggregates activate humoral and cellular inflammatory components leading an intense inflammatory response.

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 into late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). 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. The Company's strategic alliances with the U.S. Department of Health and Human Services, Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International Holdings Limited validate its scientific foundation and the utility of its product candidates.

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 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 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, most recent Registration Statement on Form S-3 (filed November 28, 2008), 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.

Source: BioCryst Pharmaceuticals, Inc