The global trial program for isavuconazole focuses on patients with invasive candidiasis including candidemia and patients with aspergillosis.
The program targets two very significant patient groups with high medical need, cancer patients and patients in the intensive care unit setting. The ability to switch from an intravenous to a once daily oral dosage form provides clinicians with maximum flexibility in using isavuconazole to treat these patients, said Basilea.
In the program, the first protocol is a phase III study to evaluate the safety and efficacy of isavuconazole versus voriconazole for the primary treatment of invasive fungal disease.
The second protocol is a phase III study of isavuconazole versus a candin-based regimen in the treatment of candidemia and other invasive candida infections. This trial will also include mild to moderate renally impaired patients that currently have limited treatment options.
According to Basilea, currently available antifungal drugs are reported to fail in more than 50% of patients Isavuconazole was granted fast-track designation by the FDA.