Flu treatment developer seeks revisions for phase III study

Drug developer BioCryst Pharmaceuticals wants to expand the phase III clinical trial for its experimental flu treatment peramivir, but the changes could mean delays for developing the anti-viral drug.

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Drug developer BioCryst Pharmaceuticals needs more money and more time to complete a phase III clinical trial of its flu treatment peramivir, the company disclosed Thursday.

The Durham, North Carolina, company said it has submitted a revised contract proposal to  the U.S. Department of Health & Human Services. Peramivir, which has fast track designation from the Food and Drug Administration, is being developed under a $180 million contract from the Biomedical Advanced Research and Development Authority, part of HHS. BioCryst (Nasdaq:BCRX) is also seeking other contract changes including a revision of the patient focus to better demonstrate statistical significance of the treatment, an increase in the sample size and an expansion of the study to additional geographic regions. BioCryst expects the changes will increase the time needed to enroll patients and it also asked to extend the patient enrollment timeline to beyond the end of 2011.

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Peramivir is being developed to inhibit an enzyme critical to the spread of influenza within a host patient. The company says that this type of treatment could be important for patients hospitalized with severe and possibly life-threatening influenza. The antiviral treatment caught the eye of the FDA after the swine flu became a pandemic in 2009. Despite peramivir’s experimental status, the FDA that year granted emergency authorization for its use in certain hospitalized patients with suspected or confirmed H1N1 influenza. That authorization ended last June.

CEO Jon Stonehouse announced last fall that BioCryst would relocate its headquarters from Birmingham, Alabama, to Durham, North Carolina, where the company already had much of its R&D operations.