BioCryst gets FDA OK to begin intravenous studies on flu inhibitor peramivir

By Ted A. Knutson

Washington, Dec. 22 - BioCryst Pharmaceuticals, Inc. announced Thursday the Food and Drug Administration has given verbal approval to begin studies with intravenous peramivir, the company's influenza neuraminidase inhibitor.

In preclinical studies, peramivir has shown potent, broad-spectrum activity against multiple strains of flu, including the H5N1 virus.

"This communication from the FDA allows us to move forward with our clinical development of injectable formulations of peramivir," said Charles E. Bugg, Ph.D., chairman and chief executive officer of BioCryst, in a news release. "Our clinical plan includes initial development of the intravenous formulation of peramivir, for treatment of acutely ill influenza-infected patients. In addition, we are conducting preclinical studies with intramuscular formulations, which will be directed at patients with earlier stages of influenza infections.

"We are pursuing both of these development programs in close collaboration with research groups at the National Institutes of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH)."

Phase 1 clinical testing of the intravenous formulation is expected to begin early in the first quarter of 2006 at the National Institutes of Health Clinical Center in Bethesda, Md.

Birmingham, Ala.-based BioCryst designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases and viral infections.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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