Basilea Announces Start of Phase III Program for Isavuconazole
Basilea Pharmaceutica Ltd. announced the opening of two primary-treatment phase III clinical trials for isavuconazole (BAL8557) in patients with invasive systemic fungal infections caused by yeasts and molds. The global trial program for isavuconazole (BAL8557) focuses on patients with invasive candidiasis including candidemia and patients with proven or probable aspergillosis. Isavuconazole was granted fast-track designation by the U.S. Food and Drug Administration (FDA).
According to the company, Isavuconazole has a potent and broad spectrum of activity against both yeasts and molds. This new triazole is developed as a water-soluble pro-drug to allow safe and simple intravenous administration without contraindication in renally impaired patients. In addition, taken as convenient once daily or once weekly capsules, the prodrug results in rapid and almost complete absorption and distribution to infected tissues.
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