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news.BioCryst Pharmaceuticals is seeking approval from the FDA to begin human trials of injectable formulations of the company's anti flu drug, peramivir, which has shown activity against multiple strains of flu, including the H5N1 virus in preclinical studies.
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Peramivir is part of a class of antiviral agents that work by inhibiting viral neuraminidase, an enzyme essential for the influenza virus to replicate and infect its hosts.
In preclinical tests, peramivir has been shown to be a potent and selective inhibitor of influenza A and B neuraminidases and the compound was generally well tolerated in extensive clinical studies as an oral formulation. To date, both intravenous and intramuscular formulations of peramivir have been evaluated in preclinical animal models with success.
“We believe an injectable formulation of peramivir has considerable potential for treating life-threatening strains of influenza,” said Dr Charles Bugg, chairman and CEO of BioCryst.”
There are currently four drugs available for the treatment of seasonal influenza, but there are no drugs yet approved specifically to treat avian flu (H5N1). In preclinical studies, multiple avian influenza strains, including H5N1 have been shown to be sensitive to peramivir, leading researchers to believe that in the proper formulation, the drug may be effective against the virus in humans.
In addition, preclinical studies have shown that peramivir is active against influenza strains that have developed resistance to Tamiflu or Relenza, especially at the blood levels the company expects to achieve in its initial phase I studies.