The Phase II trial compared the efficacy and safety of five days of therapy with either 200mg intravenous (IV) peramivir per day, 400mg IV peramivir per day or 75mg oral oseltamivir twice a day, in patients who required hospitalization related to influenza.
The primary objective of the study was to evaluate time to clinical stability, which is a composite endpoint comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. This type of endpoint has previously been used in pneumonia studies, but not in influenza. Secondary objectives of the study included evaluation of viral shedding, mortality, clinical relapse and time to resumption of usual activities.
In the primary efficacy population, for all groups combined, the study demonstrated a median of 25.3 hours to clinical stability, a median of 2.0 log reduction in time weighted change from baseline in viral titer, zero mortality, no clinical relapse and a median of 10.8 days of time to resumption of usual activities. There were no statistically significant differences in any of the efficacy endpoints between the three treatment arms. Peramivir was generally safe and well-tolerated at these dose levels.
William Sheridan, chief medical officer of BioCryst, said: “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. According to the US 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.”