First patient dosed in pivotal Phase 3 trial for novel antifungal for both treatment and prevention of serious fungal infectionsby Press Release
Cidara Therapeutics, Inc., a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, and Mundipharma announced that the first patient has been dosed in its ReSPECT pivotal Phase 3 clinical trial evaluating the efficacy and safety of the company’s lead antifungal candidate, rezafungin, for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections.
Johan A. Maertens, M.D., Ph.D., FECCM, Professor of Internal Medicine and Hematology, University Hospitals Leuven, Leuven, Belgium and investigator in the ReSPECT study, said, “Rezafungin has the potential to become the new standard of care to prevent invasive fungal disease in patients undergoing allogeneic blood and marrow transplants. The cocktail of preventative options used today has significant limitations, such as toxicities, hazardous drug-drug interactions and patient compliance. With one drug, rezafungin, given once-weekly, we may be able to overcome these substantial limitations to improve patient outcomes in this highly immunosuppressed population.”
Jeffrey Stein, Ph.D., president and chief executive officer of Cidara, added, “The ReSPECT pivotal Phase 3 trial studying rezafungin for the prevention of severe fungal infections, along with our ongoing ReSTORE Phase 3 trial evaluating rezafungin for the treatment of invasive Candida infections, positions rezafungin to potentially become the first new antifungal approved for both the treatment and prevention of serious fungal infections in nearly 15 years. Patients with compromised immune systems face complex drug regimens when undergoing BMT and experience a high mortality rate if infected. Shifting the antifungal standard of care to a single once-weekly drug, rezafungin, which has the potential to protect against three deadly pathogens, could significantly transform the approach and outcomes for patients and health care providers alike.”
Cidara is supported in the ongoing development of rezafungin by Mundipharma, who will be responsible for bringing the therapy to patients outside the U.S. and Japan.
Brian Sheehan, senior vice president Innovation at Mundipharma commented: “We are pleased to be working in partnership with Cidara Therapeutics on this promising therapy in an area that has seen little innovation in over a decade. The launch of this pivotal Phase 3 trial is an important milestone in our joint efforts to support vulnerable patients around the world.”
The ReSPECT trial 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.
Further information on the ReSPECT trial can be found at: https://clinicaltrials.gov/ct2/show/NCT04368559
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