- Corporate
Isavuconazole
Isavuconazole is a novel water-soluble, broad-spectrum antifungal. The investigational drug is in clinical phase III development for the treatment of severe invasive fungal infections. Isavuconazole's extended antifungal spectrum covers most yeasts and molds including fluconazole resistant candida strains, aspergillus and zygomyces that cause serious infections in patients with a weakened immune system. The U.S. Food and Drug Administration (FDA) granted isavuconazole fast track designation.
Pre-clinical and clinical data generated to date indicate that isavuconazole has the potential to overcome many limitations of current therapies for the treatment of invasive fungal infections. Isavuconazole is given by intravenous infusion or oral capsules with high oral bioavailability that provides an option for intravenous-oral step-down. It can be administered in convenient once-daily or once-weekly dosing regimens supporting patient-tailored treatment schemes. The drug has predictable and dose proportional pharmacokinetics that are important to ensure adequate therapeutic drug levels in patients with life-threatening fungal infections. Human studies to-date suggest the potential for fewer clinical drug-drug interactions. The intravenous dose form has the potential to be given safely to patients with renal impairment.
Basilea Pharmaceutica International Ltd. has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for isavuconazole in phase III clinical development for the treatment of life-threatening invasive fungal infections.
Ongoing phase III program
The clinical program includes three international phase III trials with centers in the U.S., Europe and other regions that target respectively, yeast infections (candidemia / invasive candida infections), mold infections (invasive aspergillosis) and finally rare molds and renally impaired patients with aspergillosis.Early 2010 an Independent Data Safety Monitoring Board recommended the continuation of the phase III clinical trial of isavuconazole for the treatment of invasive Aspergillus infections based on a futility analysis of the first 180 patients.
The need for new antifungal therapies
The expansion of the immunocompromised patient population including cancer patients with chemotherapy induced neutropenia and transplant recipients receiving immunosuppressive therapy has led to an increased incidence of invasive fungal infections. The overall rate of invasive fungal infections in these patients is approximately 25% and mortality ranges from 30 - 90%. In major markets alone, an estimated seven million patients are at risk for invasive fungal infections with more than two million patients treated. There is a high medical need to address the limitations of current therapies, most importantly the gaps in the antifungal spectrum, unwanted side effects, limited dosing flexibility as well as the development of resistance.
© 2013 Basilea Pharmaceutica Ltd.
