Positive top-line Phase III results for rezafungin

US biotech Cidara Therapeutics (Nasdaq: CDTX) and the UK’s Mundipharma today announced positive top-line data from the pivotal ReSTORE Phase III clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential first-line treatment for candidemia and invasive candidiasis.

Rezafungin met the primary endpoint for the US Food and Drug Administration New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency Marketing Authorization Application (MAA) submission of global cure at Day 14. Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.

“The results of the ReSTORE trial reinforce our belief that rezafungin has the potential to have a significant impact on the care of patients battling difficult-to-treat and often deadly invasive Candida infections,” said Jeffrey Stein, president and chief executive of Cidara.