Basilea opens new phase III study in special patient populations for its broad-spectrum antifungal isavuconazole
Basilea Pharmaceutica Ltd. announced that it has opened an additional phase III study to evaluate the efficacy and safety of isavuconazole in treating serious and life-threatening invasive fungal infections. Isavuconazole's breadth of spectrum in vitro and its favorable pharmacokinetic profile formed the basis of this open label study.
Basilea is currently conducting pivotal randomized phase III studies focusing on first-line treatment against invasive aspergillus or candida bloodstream infections. This additional supportive international multicenter safety and efficacy study will include aspergillosis patients with impaired renal function and patients with rare mold infections. The study is expected to provide additional confirmation of the potential advantages of intravenous and oral isavuconazole over existing antifungals in terms of consistently effective drug levels, convenience, and clinical safety. These data are intended to complement the planned regulatory package.
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