Flu treatment company BioCryst to use $55M for phase III trials

The NC biotech won proposed changes to federal funding that triggered this new infusion of cash. BioCryst Pharmaceuticals’ additional $55 million for flu treatment clinical trials and a new drug application is “money that will get us to the finish line,” CEO Jon Stonehouse said.

The experimental flu treatment under development by BioCryst Pharmaceuticals (NASDAQ:BCRX) has landed an additional $55 million to carry the compound through late stage clinical trials.

BioCryst, which is based in Durham, North Carolina, is developing its flu treatment peramivir through a contract with the Biomedical Advanced Research and Development Authority, or BARDA, a part of the U.S. Department of Health & Human Services. BioCryst said that BARDA had modified the $180 million contract to award BioCryst an additional $55 million to complete phase III clinical trials.

“This is the money that will get us to the finish line,” CEO Jon Stonehouse told analysts Friday morning on a conference call discussing the announcement.

BioCryst in January submitted a revised contract proposal to HHS. Besides seeking additional funds, BioCryst asked for other changes such as 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.

The revised contract allows the changes that BioCryst sought. The contract is also extended two years through Dec. 31, 2013. With the additional funds, BioCryst expects to have enough funding to take the treatment through the filing of a new drug application for intravenous peramivir.

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 particularly for patients hospitalized with severe and possibly life-threatening influenza.

Peramivir has already been used by some patients outside of clinical trials. The treatment received a temporary emergency authorization in 2009, during the swine flu pandemic. The Food and Drug Administration granted emergency authorization of peramivir for certain patients hospitalized with H1N1 influenza. That emergency authorization ended in June 2010.