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

29-Nov-2010 - Switzerland

Basilea Pharmaceutica Ltd. announced that in consultation with the U.S. food and Drug Administration (FDA) Basilea and its partner Astellas Pharma Inc. have agreed to use 'all-cause mortality' as the primary endpoint of the phase III clinical study investigating isavuconazole for the treatment of invasive aspergillosis. The company confirms the previously communicated timelines for the ongoing phase III program.

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.

https://www.bionity.com/en/news/126670/basilea-and-astellas-update-isavuconazole-phase-iii-trial-in-consultation-with-fda.html