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Basilea's isavuconazole meets in Phase III

October 1, 2013 12:47 AM UTC

Basilea Pharmaceutica AG (SIX:BSLN) and partner Astellas Pharma Inc. (Tokyo:4503) said once-daily isavuconazole met the primary endpoint of non-inferiority to twice-daily voriconazole in reducing all-cause mortality from baseline to day 42 (18.6% vs. 20.2%) in the Phase III SECURE trial to treat invasive fungal disease caused by Aspergillus species or other filamentous fungi. The partners said the pre-specified non-inferiority margin was 10%. The double-blind, international trial enrolled 516 patients.

In July, Basilea completed enrollment of 150 patients in the Phase III VITAL trial of isavuconazole to treat Aspergillus infections in patients with pre-existing renal impairment or rare fungal infections. Isavuconazole is also in the Phase III ACTIVE trial to treat candidemia and other invasive Candida infections. Basilea said data from SECURE and VITAL could form the basis of an initial regulatory filing for isavuconazole in early 2014, but the partners declined to disclose details or a time frame for when VITAL data are expected. Isavuconazole is a broad spectrum water-soluble azole antifungal. ...