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.
Basilea said that 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.
Additionally, 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.
Basilea chief medical officer Achim Kaufhold said that it was 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 new drug," Kaufhold said.
"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."