Cidara’s Rezafungin Hits Approvable Endpoints For Candida Infections

Cidara Therapeutics, Inc. is on track to file its novel echinocandin antifungal agent rezafungin in mid-2022 to treat candidemia and invasive candidiasis in both the US and Europe, with positive results from the pivotal Phase III ReSTORE study. In a top-line data readout on 14 December, rezafungin demonstrated non-inferiority to caspofungin, the current standard of care, on co-primary endpoints of all-cause mortality at day 30 and global cure at day 14.

Cidara designed ReSTORE to demonstrate non-inferiority to the established echinocandin on the co-primary endpoints to satisfy both the US Food and Drug Administration and the European Medicines Agency, CEO Jeffrey Stein explained in an interview. The endpoints comprise data Cidara would have wanted to collect anyway, Stein told Scrip