Cidara and Mundipharma Tout Promising Phase 3 Data of Antifungal Drug

Cidara Therapeutics and UK-based Mundipharma said their joint antifungal investigational drug rezafungin showed promise in a late-stage study.

In the phase 3 study with 199 participants with invasive candidiasis — a fungal infection in the bloodstream — the investigational drug was compared with the standard of care, Merck’s Cancidas (caspofungin).

The primary endpoint of noninferiority was achieved, with 59.1 percent of patients taking rezafungin experiencing a cure by day 14 compared to 60.6 percent of patients taking Cancidas.

Cidara plans to submit a New Drug Application to the FDA in mid-2022. The agency previously granted rezafungin Qualified Infectious Disease Product status and an Orphan Drug designation for the treatment of invasive candidiasis.