Shares of BioCryst were buoyed by the news that the Birmingham, AL-based developer had responded to a request from the Department of Health and Human Services seeking information on how it could go about setting up an emergency stockpile of its experimental flu drug peramivir. And the company detailed plans for two new late-stage trials testing the intravenous antiviral drug on hospitalized patients.
In one trial researchers plan to test the efficacy of the drug used in combination with the current standard of care. That trial, which gets underway in November, will enroll 400 patients and BioCryst plans to finish in May, 2011. Another trial will further explore efficacy, safety and tolerability in patients who have the flu. That trial will wrap in June, 2011. Researchers should have no problem finding volunteers.
"The novel H1N1 2009 virus is already producing significant morbidity and mortality within North America, and I expect the burden on the healthcare system to increase in the coming weeks," said Michael Ison, an assistant professor at Northwestern University Feinberg School of Medicine and lead investigator for one of the studies. "This Phase III study will provide an important opportunity to evaluate peramivir in an area of unmet medical need for seriously ill patients in the hospital setting."