Clinical trial designers might want to pay extra attention to the travails at BioCryst. A mid-stage study of its lead therapy, the experimental flu med Peramivir, delivered disappointing data after researchers decided to switch their 1.5-inch needles with one-inch needles. The staff wanted to reduce the discomfort of injecting patients, but wound up failing to get the dose through the fat and into the muscles of many of their overweight trial subjects. As a result, the trial came up short of its primary endpoint. The drug is a potential therapy that can be deployed against a bird flu pandemic, which has earned BioCryst $103 million in U.S. research support.
BioCryst is pushing ahead, though. The FDA hasn't told the developer to repeat the Phase II trial and its researchers are rolling ahead into Phase III. Evidently no one has been fired, either, but you can bet the full dose hits home in Phase III.
- read the article from the Financial Times
- see BioCryst's original release on the trial failure