Antifungal: Rezafungin

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.

Overview

Treatment

Prevention

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.

Rezafungin’s structure yields greater stability, allowing for an extended half-life and improved safety profile.

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.

Source: CDC, Report on Antibiotic Resistant Threats. Updated Dec 2019.

An ongoing Phase 3 trial (ReSTORE; NCT03667690) is examining rezafungin for the treatment of fungal infections caused by Candida spp., including candidemia and 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.

The U.S. Food and Drug Administration (FDA) has designated rezafungin as a Qualified Infectious Disease Product (QIDP) and a Fast Track Product for both the treatment of candidemia and invasive candidiasis and for prevention of invasive fungal infections in adults undergoing allogeneic hematopoietic stem cell transplantation. The FDA has also designated rezafungin as an orphan drug for the treatment indication. The 7-year period of marketing exclusivity provided through orphan designation combined with an additional 5 years of marketing exclusivity provided by the QIDP designation positions rezafungin for a potential total of 12 years of marketing exclusivity to be granted at the time of FDA approval.