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

Exclusion Criteria

• •1. Any of the following forms of invasive candidiasis at baseline:
• •1. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
• •2. Osteomyelitis
• •3. Endocarditis or myocarditis
• •4. Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
• •5. Chronic disseminated candidiasis
• •6. Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract
• •2. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for \>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
• •3. Alanine aminotransferase or aspartate aminotransferase levels \>10-fold the upper limit of normal
• •4. Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score \>9)
• •5. 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
• •6. Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
• •7. 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
• •8. 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)
• •9. Planned or ongoing therapy at Screening with a known neurotoxic medication
• •10. Previous participation in this or any previous rezafungin study
• •11. Current participation in another interventional treatment trial with an investigational agent
• •12. 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.
• •13. Pregnant or lactating females
• •14. The Principal Investigator (PI) is of the opinion the subject should not participate in the study