A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp versus Intravenous Echinocandin followed by Oral Fluconazole (MARIO)

Invasive Candidiasis/ Candidemia

All-cause Mortality (ACM) at Day 30 in the ITT population. The percentage of subjects with Successful Global Response, as determined by the DRC at EOT (European Union [EU] only).

Key secondary endpoint: The percentage of subjects with Successful Global Response, as determined by the DRC (based on clinical response as determined by the PI, mycological response and radiological response [when applicable]) at Day 14., Efficacy Endpoints: The percentage of subjects with Successful Global Response at Day 30 and EOT as determined by the PI and the DRC., Efficacy Endpoints: The percentage of subjects with Successful Clinical Response at Day 14, Day 30 and EOT as determined by the PI and the DRC., Efficacy Endpoints: The percentage of subjects with Successful Mycological Response at Day 14, Day 30 and EOT as determined by the DRC., Efficacy Endpoints: The percentage of subjects with no recurrence at 2 weeks and 6 weeks after EOT as determined by the DRC., Efficacy Endpoints: The percentage of subjects alive with Successful Global Response at EOT and no recurrence at 6 weeks after EOT as determined by the DRC., Safety Endpoints: Frequency of treatment-emergent adverse events (TEAEs), drug-related adverse events, discontinuations due to AEs, serious adverse events (SAEs), and safety laboratory assessments., PK Endpoint: Description of ibrexafungerp plasma concentrations.

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