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Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections
Date:2/23/2009

y resolution of fever. Viral shedding (time weighted change from baseline in viral titer) was reduced by a median of -2.0 logs for peramivir 200 mg, -2.1 logs for peramivir 400 mg, and -1.9 logs for oseltamivir (p=0.908). There was no mortality in the primary efficacy population, and there were no clinical relapses. Patients were discharged from hospital after a median of 4.0 days for peramivir 200 mg, 3.8 days for peramivir 400 mg, and 4.0 days for oseltamivir (p=0.994). The median number of days required for resumption of usual activities was 8.8 days for peramivir 200 mg, 9.0 days for peramivir 400 mg, and 13.7 days for oseltamivir (p=0.276).

"We are encouraged by these data and are currently working with the U.S. Food and Drug Administration to determine the next steps for peramivir as a treatment for patients hospitalized with influenza," said Dr. William P. Sheridan, BioCryst's Chief Medical Officer. "There are currently no approved treatment options for the 200,000 patients hospitalized for influenza each year and we believe peramivir may be a potential new option for these patients."

"This study greatly enhances our knowledge of the clinical and virologic course of influenza in hospitalized patients who receive neuraminidase inhibitors," stated Dr. Ison. "Peramivir holds promise as a once-daily intravenous treatment that is safe and potentially effective for use in patients with acute influenza, including the elderly and patients with underlying cardiac or pulmonary disease."

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. O
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SOURCE BioCryst Pharmaceuticals
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