Positive topline data were announced from a phase 3 trial evaluating the efficacy and safety of rezafungin, a novel broad spectrum antifungal, as a potential first-line treatment for candidemia and invasive candidiasis.
The global, randomized, double-blind ReSTORE study (ClinicalTrials.gov Identifier: NCT03667690) included 187 adults diagnosed with candidemia and/or invasive candidiasis. Patients were randomly assigned 1:1 to receive either rezafungin 400mg via intravenous (IV) infusion in week 1 followed by 200mg once weekly for a total of 2 to 4 doses (n=93) or caspofungin 70mg IV on day 1 followed by 50mg IV once daily for up to 28 days (n=94). After at least 3 days of caspofungin, patients could switch to oral fluconazole if specific parameters were met.
Results showed that rezafungin was noninferior to caspofungin for the primary endpoint of all-cause mortality at day 30 (23.7% vs 21.3%, respectively; treatment difference, 2.4; 95% CI, -9.7, 14.4). Moreover, a greater proportion of patients in the rezafungin treatment arm with candidemia achieved mycologic eradication at day 5 (78.1% vs 68.7%, respectively) and day 14 (71.9% vs 70.1%) compared with those in the caspofungin arm. Overall rates of adverse events and serious adverse events were comparable in patients receiving rezafungin and caspofungin.
“Those of us treating deadly fungal infections have been anticipating these data and if rezafungin is approved it could be an important new option for the care of our patients,” said George Thompson, MD, principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine. “I’m excited that the data from the ReSTORE trial support a potential place for once-weekly rezafungin in the treatment of critically ill patients both inside and outside the hospital.”
The Company intends to file a New Drug Application with the Food and Drug Administration in mid-2022.
Rezafungin is also being investigated for the prevention of invasive fungal disease due to Candida, Aspergillus and Pneumocystis in patients undergoing allogeneic bone marrow transplants in the ongoing global phase 3 ReSPECT trial (ClinicalTrials.gov Identifier: NCT04368559).
Cidara Therapeutics and Mundipharma announce positive topline results from the global phase 3 pivotal ReSTORE trial of rezafungin for the treatment of candidemia and invasive candidiasis. News release. Cidara Therapeutics and Mundipharma. Accessed December 14, 2021. https://www.businesswire.com/news/home/20211214005704/en/Cidara-Therapeutics-and-Mundipharma-Announce-Positive-Topline-Results-from-the-Global-Phase-3-Pivotal-ReSTORE-Trial-of-Rezafungin-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis.