Blaming a flawed trial design, BioCryst Pharmaceuticals has reported its seasonal and avian flu vaccine peramivir failed a Phase II trial. Although the 313 subjects receiving single doses of peramivir showed improvement over a placebo, the results were not statistically significant. BioCryst believes that due to the introduction of a shorter injection needle in the Phase II trial compared to the Phase I trial, only one-third of subjects received an adequate intramuscular injection.
"We are clearly disappointed that we did not achieve the primary endpoint across the entire study population...Based on these results, we have a clear and concise plan to correct the issues identified in this study and continue our preparations to initiate our Phase III program by year end,"Â said Jon P. Stonehouse, President and CEO of BioCryst Pharmaceuticals. The U.S. government funded the trial and extended a $102.6 million contract to BioCryst to develop the drug.
- see BioCryst's release for more
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