Basilea opens new phase III study in special patient populations for its broad-spectrum antifungal isavuconazole
Basel, Switzerland, April 2008
Basilea Pharmaceutica Ltd. (SWX:BSLN) announces 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.
Isavuconazole has a potent, broad spectrum of activity against both yeasts and molds in vitro. This new triazole is developed as a water-soluble pro-drug to allow the potential intravenous administration in renally impaired patients. In addition, when taken as once daily or once weekly capsules, the prodrug results in rapid absorption and distribution of isavuconazole to infected tissues.
Basilea successfully completed its phase II trial in esophageal candidiasis with both high clinical cures rates and a safety profile comparable to gold standard fluconazole therapy. Clinical drug interaction studies have illustrated attractive pharmacokinetic features and the potential for less drug-drug interactions than a number of broad-spectrum antifungal drugs in current use. Isavuconazole is in phase III testing with global primary-treatment phase III trials for the treatment of invasive yeast and mold infections.
Isavuconazole is the only azole to-date to have been granted FDA fast track status to the company’s knowledge.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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