Basilea and Astellas update isavuconazole phase III trial in consultation with FDA

All-cause mortality, which was one of the secondary study endpoints, will become the primary endpoint of the phase III clinical trial investigating isavuconazole in invasive aspergillosis. The total target number of patients will be around 510 in the study. The previous primary outcome measure of ‘overall response’ (clinical, mycological and radiological response) will continue to be assessed in the study as a secondary endpoint. “It is important that development programs keep up with scientific advances and take into account current regulatory thinking. We will continue to assess the overall response as a secondary endpoint to obtain a comprehensive clinical profile of this novel drug,” said Professor Achim Kaufhold, M.D., Chief Medical Officer of Basilea. “The change in primary endpoint does not have any impact on our ongoing preparations to restart the isavuconazole phase III program as the operational aspects of the way the study is conducted remain unchanged.”

This decision does not affect the previously communicated timelines for the ongoing phase III program of isavuconazole. Initiation of first sites is anticipated at year-end or early 2011 and the availability of phase III results continues to be expected in 2013.

About isavuconazole
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. The drug has predictable and dose proportional pharmacokinetics that are important to ensure adequate therapeutic drug levels in patients with life-threatening fungal infections. The intravenous dose form has the potential to be given safely to patients with renal impairment.

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 aspergillosis in renally impaired patients.

Earlier this year, an Independent Data Safety Monitoring Board recommended 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. Isavuconazole has been granted fast track designation by the U.S. Food and Drug Administration (FDA).

Contact
Media Relations Adesh Kaul Head Public Relations & Corporate Communications T.: +41 61 606 1460 E.: media_relations@basilea.com

Investor Relations Barbara Zink, Ph.D., MBA Head Corporate Development T.: +41 61 606 1233 E.: investor_relations@basilea.com