Study of anti-fungal isavuconazole meets primary endpoint

Positive topline data from the SECURE Phase III study of isavuconazole, from Astellas/Basilea Pharma, achieved its primary objective in demonstrating non-inferiority versus voriconazole for the primary treatment of invasive Fungal Disease caused by Aspergillus species or certain other filamentous fungi. Isavuconazole was effective as determined by the primary endpoint of all-cause mortality through day 42 in the intent-to-treat population. The all-cause-mortality was 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole group.

In addition, the key secondary endpoint of overall success rate (composite of clinical, mycological, radiological responses) at the end-of-therapy was similar between isavuconazole and voriconazole (35.0% and 36.4%, respectively). Adverse events were reported in 96.1% and 98.5% of patients in the isavuconazole and voriconazole treatment groups, respectively. The most frequent events were nausea, vomiting, pyrexia, diarrhea and hypokalaemia.