Cidara’s Rezafungin Hits Approvable Endpoints For Candida Infections

 
• By Joseph Haas
  
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Phase III data for the novel echinocandin demonstrated non-inferiority to caspofungin for all-cause mortality at day 30 and for global cure at day 14. Regulatory filings are planned for 2022.

IV solution in a child's patients hand
Cidara hopes its weekly I.V. antifungal will improve therapy 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...

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