The primary goal of this phase III study is to demonstrate statistical non-inferiority of isavuconazole versus the comparator, current standard- of-care voriconazole in the treatment of invasive Aspergillus infections.
The futility analysis was included in the clinical trial design to ensure that the trial could be stopped early if it appeared that the study would be eventually unable to demonstrate non-inferiority for isavuconazole. The IDSMB recommendation was based on the analysis of the primary efficacy endpoint of 180 patients.
Anthony Man, CEO of Basilea Pharmaceutica, said: “Since the data remains blinded, the efficacy results will not be known until the study is completed, however, we are very pleased that the study has successfully passed this important interim assessment point. Regular assessments of safety parameters by the IDSMB have not revealed any major or unexpected safety concerns. With numerous differentiating features over current therapies, isavuconazole has the potential for a best-in-class antifungal.
“The recruitment of new patients into the phase III clinical program is expected to resume in the first half of 2010 and topline data are anticipated to be available in 2011.”