Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

Inclusion Criteria

• Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on his/her behalf.
• Males or females ≥18 years of age.
• Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
• ≥1 blood culture positive for yeast or Candida OR
• Positive test for Candida from a Sponsor-approved rapid in vitro diagnostic (IVD) OR
• Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
• Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤12 hours prior to the qualifying positive culture through time of randomization.
• Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
• Female subjects of childbearing potential (all female subjects between 18 years 48 hours (e.g., >2 doses of a once daily antifungal agent or >4 doses of a twice daily antifungal agent) ≤4 days (96 hours) before randomization

a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible

• Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal
• Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9)
• Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis
• Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
• Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher
• History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)
• Planned or ongoing therapy at Screening with a known neurotoxic medication
• Previous participation in this or any previous rezafungin study
• Current participation in another interventional treatment trial with an investigational agent
• Recent use of an investigational medicinal product within 28 days of the first dose of study drug or presence of an investigational device at the time of screening.
• Pregnant or lactating females
• The Principal Investigator (PI) is of the opinion the subject should not participate in the study