Isavuconazole: Phase III amended

Basilea amended a halted, double-blind, international Phase III trial comparing isavuconazole vs. voriconazole to evaluate a new primary endpoint of all-cause mortality, which was previously a secondary endpoint. The previous primary endpoint, overall response, will now be assessed as a secondary endpoint. The company also increased enrollment to 510 from 360 patients. Basilea said the changes will not affect the timeline of the trial, which is slated to restart by year end or early next year. Astellas partnered to co-develop isavuconazole worldwide, with an option to include Japan (see BioCentury, March 1). ...