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.
Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology agents to fight drug resistance and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting.