Basilea's antifungal isavuconazole passed phase III clinical trial futility analysis
Basilea Pharmaceutica Ltd. announced that based on a futility analysis of the isavuconazole phase III trial for the treatment of invasive Aspergillus infections, the Independent Data Safety monitoring Board (IDSMB) has recommended the continuation of the study.
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. In life-threatening infections such as invasive fungal infections it is standard to ensure that patients receive the most effective treatment at the earliest stage and are not unnecessarily exposed to potentially ineffective investigational drugs. The IDSMB recommendation was based on the analysis of the primary efficacy endpoint of 180 patients.
"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," said Dr. Anthony Man, CEO Basilea Pharmaceutica Ltd. "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."
Pre-clinical and clinical data generated to date indicate that isavuconazole has the potential to overcome many of the key limitations of current therapies for the treatment of invasive fungal infections. Isavuconazole shows high bioavailability and provides for a seamless intravenous-oral step-down option. The drug has predictable, linear pharmacokinetics with no relevant food effect, and the potential for fewer drug-drug interactions. The ability to rapidly achieve adequate plasma and tissue concentrations and to maintain these levels long enough to avoid recurrence is essential for the successful treatment of these life-threatening invasive fungal infections. In addition, isavuconazole is highly water-soluble circumventing the need to add potentially kidney-damaging solubulizing agents to the i.v. formulation.
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