Astellas’ antifungal study reports positive results

Japanese drug major Astellas Pharma (TYO: 4503) has announced positive topline data from the Phase III invasive aspergillosis study (SECURE) into isavuconazole, the antifungal agent being co-developed with Swiss company Basilea Pharmaceutica (SIX: BSLN).

Study details

The randomized, double-blind isavuconazole study 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. The 95% confidence interval of the treatment difference between isavuconazole and voriconazole was within the pre-specified non-inferiority margin of 10%.