Cidara is developing a novel once-weekly echinocandin, rezafungin, for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism, enhancing its efficacy and safety potential for patients.
Rezafungin is a novel, once-weekly antifungal being developed for the treatment and prevention of serious fungal infections.
Rezafungin is a member of the echinocandin class of drugs. Echinocandins are considered the safest antifungal drugs available and are suggested by the Infectious Disease Society of America (IDSA) as first-line treatment for fungal infections. Rezafungin’s structure and properties have been precisely refined to retain the safety benefits of echinocandin drugs while enhancing its pharmacokinetic and pharmacodynamic properties to create a longer-lasting, next-generation treatment and preventative, capable of addressing even drug-resistant species.
To date, data demonstrate that rezafungin has potent antifungal activity against representative strains of Candida spp., Aspergillus spp., Pneumocystis spp. and dermatophytes. In addition, rezafungin has potent activity against fungal pathogens designated as Urgent and Serious Threats by the CDC.
A recently completed Phase 3 trial (ReSTORE; NCT03667690) examining rezafungin demonstrated non-inferiority on the FDA and EMA pre-specified primary endpoints versus the daily standard of care for the treatment of candidemia and/or invasive candidiasis.
An ongoing Phase 3 trial (ReSPECT; NCT04368559) is examining rezafungin for the prevention of fungal infections, caused by Candida, Aspergillus and Pneumocystis, in patients undergoing allogeneic blood and marrow transplant.
In the United States, the FDA has granted rezafungin the following designations:
- For the treatment of candidemia and invasive candidiasis, rezafungin has designations for Qualified Infectious Disease Product, or QIDP, Fast Track, and Orphan Drug. QIDP and Orphan Drug designations together provide a total of 12 years of marketing exclusivity in the United States from the time of FDA approval.
- For the prophylactic use in patients undergoing allogeneic blood and marrow transplant, rezafungin has designations for QIDP and Fast Track. The QIDP designation provides a total of five years of marketing exclusivity in the United States from the time of FDA approval.