Gil Roth09.30.13
Astellas Pharma Inc. has posted positive topline data from its Phase III trial of antifungal agent isavuconazole against invasive aspergillosis study (SECURE). Isavuconazole is being co-developed with Basilea Pharmaceutica Ltd.
The randomized, double-blind isavuconazole study (SECURE) 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%.
In addition, the key secondary endpoint of overall success rate (composite of clinical, mycological, radiological responses) at the end-of-therapy in patients with proven/probable disease was similar between isavuconazole and voriconazole (35.0% and 36.4%, respectively). This outcome was based on a blinded assessment by the Independent Data Review Committee.
The company has also completed enrollment in VITAL, the open-label Phase III trial of isavuconazole, including patients with invasive fungal disease caused by mucormycetes and other emerging fungal pathogens and patients with aspergillosis and pre-existing renal impairment has been completed. Based on the investigator-reported data, approximately 45 patients were enrolled with mucormycosis and a similar number of patients were enrolled with pre-existing renal impairment. Review of diagnosis and outcomes by an Independent Data Review Committee is ongoing.
Enrollment is continuing for ACTIVE, the randomized, double-blind Phase III trial of isavuconazole IV and oral versus caspofungin IV followed by oral voriconazole for the treatment of invasive Candida infections.
The randomized, double-blind isavuconazole study (SECURE) 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%.
In addition, the key secondary endpoint of overall success rate (composite of clinical, mycological, radiological responses) at the end-of-therapy in patients with proven/probable disease was similar between isavuconazole and voriconazole (35.0% and 36.4%, respectively). This outcome was based on a blinded assessment by the Independent Data Review Committee.
The company has also completed enrollment in VITAL, the open-label Phase III trial of isavuconazole, including patients with invasive fungal disease caused by mucormycetes and other emerging fungal pathogens and patients with aspergillosis and pre-existing renal impairment has been completed. Based on the investigator-reported data, approximately 45 patients were enrolled with mucormycosis and a similar number of patients were enrolled with pre-existing renal impairment. Review of diagnosis and outcomes by an Independent Data Review Committee is ongoing.
Enrollment is continuing for ACTIVE, the randomized, double-blind Phase III trial of isavuconazole IV and oral versus caspofungin IV followed by oral voriconazole for the treatment of invasive Candida infections.