Cidara Therapeutics Doses First Patient in Pivotal Phase 3 ReSPECT Trial of Rezafungin for Prevention of Invasive Fungal Disease in Patients Undergoing Allogeneic Blood and Marrow Transplantation
Cidara is supported in the ongoing development of rezafungin by Mundipharma, who will be responsible for bringing the therapy to patients outside the
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
About Invasive Fungal Disease
Each year, an estimated 1.5 million people with compromised or suppressed immune systems die of invasive fungal infections worldwide.1 The current standard of care for the prevention of invasive fungal disease requires complex patient-specific plans and drug cocktails that are subject to change due to the underlying disease, toxicities and the local epidemiology of fungal infections.2,3 Patients who have received a blood and marrow transplant, 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.3
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin were specifically designed to improve upon a clinically validated mechanism, enhancing its efficacy and safety potential for patients. Cidara and its strategic partner Mundipharma are currently conducting a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial)4, as well as a second Phase 3 clinical trial of once-weekly rezafungin for prevention against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).5 Mundipharma has exclusive rights to develop and commercialize rezafungin in all markets outside of
Cidara is developing therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company’s portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting influenza and other viral diseases from Cidara’s proprietary Cloudbreak antiviral platform. Cidara is headquartered in
About the Mundipharma network
Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward. With a high performing and learning organisation that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.
Safe Harbor Statement
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, whether we can successfully develop rezafungin, establish it as a new standard of care or whether rezafungin can overcome limitations of existing therapies, whether the Phase 3 development program for rezafungin will be successful and be approved both for treatment and prevention of serious fungal infections, or whether as a therapy it will protect against deadly pathogens and transform the approach and outcomes for patients and healthcare providers. Risks that contribute to the uncertain nature of the forward-looking statements include, but are not limited to: the success and timing of Cidara’s clinical trials; regulatory developments in
Karen O’Shea, Ph.D.
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- Bongomin F, Gago S, Oladele RO et al. Global and Multi-National Prevalence of Fungal Diseases-Estimate Precision. J Fungi (
- Vazquez L. Antifungal Prophylaxis in Immunocompromised Patients. Mediterr J Hematol Infect Dis. 2016; 8(1): e2016040.
- Fleming S, Yannakou CK, Haeusler GM et al. Consensus guidelines for antifungal prophylaxis in haematological malignancy and haemopoietic stem cell transplantation, 2014.
Internal Medicine Journal2014; 44 (12b):1283-97.
Source: Cidara Therapeutics, Inc.