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BioCryst Reports Results From the First-Ever Completed Active-Controlled Phase 2 Study in Hospitalized Influenza
Date:10/27/2008

at insight into the course of treatment for patients who are hospitalized for influenza. The results indicate a potential role for antiviral therapy, which is critical as currently there are no antivirals approved for patients hospitalized for acute serious or potentially life-threatening influenza," said Dr. Michael Ison, Assistant Professor, Divisions of Infectious Diseases and Organ Transplantation at Northwestern University Feinberg School of Medicine and Principal Investigator in the study.

"We are very encouraged by how quickly the virus cleared, how well the patients did overall and the safety profile of peramivir in this study," said Dr. William P. Sheridan, BioCryst's Chief Medical Officer. "According to the U.S. Centers for Disease Control, 36,000 people die of complications from influenza each year. Therefore, the observed zero mortality in patients with confirmed influenza in this study is an important finding."

The multicenter, randomized, double-blind, double-dummy, active- controlled, Phase 2 study enrolled 137 patients, who tested positive by rapid antigen test (RAT) for influenza and had one or more criteria for hospitalization, namely: age greater than or equal to 60 years, chronic lung disease, congestive heart failure, diabetes mellitus, low oxygen saturation, low blood pressure, or severity of illness requiring supportive care. Of the 137 patients randomized, 122 age 19 to 101 years had influenza confirmed by polymerase chain reaction (PCR) testing and were included in the intent-to- treat infected (ITTI) patient population; 41 patients received oseltamivir 75 mg orally twice-daily, 41 patients received 200 mg i.v. peramivir once-daily and 40 patients received 400 mg i.v. peramivir once-daily.

The study was conducted in the United States, Canada, Hong Kong, Singapore, Australia, New Zealand, and South Africa.

Health and Human Services Contract

BioCryst is advancing the clinical development of peramivir under te
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SOURCE BioCryst Pharmaceuticals, Inc.
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