These trials were conducted to investigate the safety, tolerability and pharmacokinetics of intravenous and intramuscular injections of peramivir in healthy volunteers.
The company said that in additional studies on animal subjects, peramivir had shown that strong anti-influenza activity including a good response to the H5N1 avian influenza virus.
In the studies performed in collaboration with investigators at the National Institute of Health and at Healthcare Discoveries, over 60 healthy volunteers received doses of intravenous peramivir each day for up to 10 days. All doses were well tolerated with no serious adverse events reported. Pharmacokinetic analyses showed that peak blood levels of peramivir were in the range of levels which may be sufficient to inhibit influenza virus infection.
In January 2006, BioCryst received FDA fast track designation for the development of peramivir injection for this indication.