Phase 3 study of peramivir for treatment of influenza

BioCryst Pharmaceuticals announced positive results from two Phase 3 studies of peramivir intravenous (IV) in patients with seasonal influenza. The studies were sponsored by BioCryst's partner Shionogi & Co. and conducted during the 2008-2009 influenza season. In the first of these studies, a total of 1,099 patients with uncomplicated seasonal influenza were enrolled in a three-armed, multi-center, randomized, double-blind, multi-national Phase 3 study of peramivir IV. This study compared the efficacy and safety of a single dose of peramivir (either 300 mg or 600 mg) to treatment with Tamiflu (oseltamivir phosphate, from Roche) 75 mg twice a day for five days. Both the 300 mg and 600 mg single dose peramivir groups demonstrated non-inferiority for the primary endpoint, time to alleviation of symptoms (TTAS), compared to the oseltamivir group. The medians for TTAS for the peramivir 300 mg, peramivir 600 mg and oseltamivir groups were 78 hours, 81 hours and 81.8 hours, respectively.

Additionally, Shionogi conducted a double-blind, multi-center Phase 3 study of peramivir IV with dosing over multiple days. The study enrolled 42 influenza patients at high-risk of serious complications due to one or more qualifying conditions: diagnosis with poorly controlled diabetes mellitus, a chronic respiratory disease requiring pharmacotherapy, or current treatment with any immunosuppressive drug. Peramivir was administered at 300 mg or 600 mg per day, and the duration was adjusted (up to five days) on a case-by-case basis, depending on the patient's temperature and clinical condition. In this study, the median time to alleviation of symptoms in all 37 evaluable patients treated with either 300 mg or 600 mg peramivir daily was 68.6 hours.

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against various viral strains, including the novel influenza A (H1N1) virus.

For more information call (205) 444-4600 or visit www.biocryst.com.