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

Every year, an estimated 1.5 million people with compromised or suppressed immune systems die worldwide of invasive fungal infection. For such patients, preventing infection from developing in the first place with antifungal prevention is increasingly important.

Patients who have received a blood and marrow transplant (BMT), cancer chemotherapy or solid organ transplant may receive prophylaxis to prevent deadly Candida, Aspergillus and/or Pneumocystis infections for several weeks to over a year, depending on the period of immunosuppression or development of Graft Versus Host Disease. Current paradigms for the prevention of invasive fungal disease are complex because they require patient-specific plans and drug cocktails, dictated by the underlying disease and the local epidemiology of fungal infections which may be subject to change even when customized.

Rezafungin’s prolonged half-life and tolerability as an echinocandin allows for once-weekly intravenous (IV) administration to more safely prevent Candida, Aspergillus and Pneumocystis infections, including those of drug-resistant species. This confers a significant advantage for patients and physicians over the current standard of care where there is no one agent approved against all three fungi. With these benefits, rezafungin has potential to:

Be a single-agent for prophylaxis of several fungal pathogens – Candida, Aspergillus and Pneumocystis, displacing more toxic azoles and trimethoprim/sulfamethoxazole (TMP/SMX)

Be the only echinocandin to facilitate shorter and less costly hospital stays

Be the only echinocandin to provide more cost-effective and compliant outpatient echinocandin prophylaxis

Ongoing trials

Cidara’s ReSPECT trial (NCT04368559) is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Rezafungin, dosed once-weekly, will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survival will be measured as the primary efficacy outcome. The trial will enroll approximately 462 adults with underlying conditions, such as acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome(s), lymphoma and aplastic anemia, across approximately 30 BMT centers.