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news.BioCryst Pharmaceuticals has reported positive results from human clinical studies of the influenza inhibitor peramivir, which is being developed for the treatment of influenza, including avian flu.
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Peramivir also improved survival rates in animal subjects who were infected with the H5N1 strain of the virus – a potentially vital discovery in the attempt to find a treatment for avian influenza.
The research included a single intramuscular and three intravenous phase I studies evaluating the safety, tolerability and pharmacokinetics of injectable peramivir in healthy human volunteers. Preliminary safety results indicate that all doses were well-tolerated with no adverse laboratory events reported. Pharmacokinetic results from the trials indicate that the half-life of peramivir approaches 24 hours.
“Based on these data we anticipate entering phase II clinical testing with peramivir this coming flu season,” said Charles Bugg, CEO of BioCryst.
Additionally, BioCryst presented data taken from preclinical testing of peramivir in mice and ferrets infected with H5N1.
In the animal studies the subjects treated with peramivir had an 86% survival rate compared with a 43% survival rate observed in the untreated group. These trials suggest that further evaluation of injectable peramivir as a potential treatment for human influenza infections, including those due to highly pathogenic H5N1 strains, is warranted.
In January 2006, BioCryst received FDA fast track designation for the development of peramivir influenza including life-threatening strains of the virus.