BioCryst has reported positive results from two phase 3 studies of intravenous i.v. peramivir in patients with seasonal influenza.
Shionogi conducted a three-armed, multi-center, randomized, double-blind, multi-national phase 3 study of i.v. peramivir. It compared the efficacy and safety of a single dose of peramivir (either 300mg or 600mg) and treatment with oral oseltamivir phosphate 75mg (Tamiflu) twice a day for five days.
Additionally, Shionogi conducted a double-blind, multi-center phase 3 study of i.v. peramivir 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 300mg or 600mg 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 300mg or 600mg peramivir daily, was 68.6 hours.
William Sheridan, CMO of BioCryst, said: The clinical outcomes of these Phase 3 studies are important, especially during the declared influenza pandemic, as they indicate the promise of peramivir as a treatment for influenza.
The need for additional anti-viral treatment options for influenza remains high. BioCryst is currently finalizing its plans for peramivir Phase 3 studies intended to support US regulatory approval, while continuing to support the pre-emergency use authorization review of peramivir by the FDA, he added.