Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rezafungin · 1 trial · 2 indications
Incidence of proven and probable IFIs within 90 days post-transplant
Incidence of breakthrough IFI while on specific antifungal prophylaxis
| Arm | Type | Description |
|---|---|---|
| Prospective Intervention Cohort | EXPERIMENTAL | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV once weekly for a total duration of 4 weeks |
| Prospective Control Cohort | ACTIVE_COMPARATOR | Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant |
| Historical Control Group | ACTIVE_COMPARATOR | Patients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study |
| Name | Type | Description |
|---|---|---|
| Rezafungin | DRUG | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks. |
| Standard of care antifungal prophylaxis | DRUG | UPMC uses a tiered approach to antifungal prophylaxis, based on risk factors for IFI. Fluconazole is used for recipients with risk factors for yeast infections: choledochojejunostomy, prolonged transplant time, receipt of \>40 units of blood products within 24 hours of transplant, and Candida colonization or infection within 3 months prior to transplant. Voriconazole is used for recipients with risk factors for mould infections: re-transplantation, renal failure requiring renal replacement therapy, fulminant hepatic failure as indication for transplant, intra-abdominal/thoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections. |
Inclusion Criteria: * Liver transplant recipient * 18 years of age or older * ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy an...
Rezafungin is an investigational small molecule antifungal being developed by CorMedix Inc. (ticker CRMD). It is in Phase 3 development for the prevention of infection in liver transplant patients. It is an antifungal agent in the infectious disease therapeutic area.
Rezafungin is being studied as prophylaxis to prevent fungal infection in liver transplant recipients. The Phase 3 trial enrolls adult liver transplant patients at risk of infection. It is investigational and has not been approved for this use.
Rezafungin targets 1,3-beta-D-glucan synthase, an enzyme involved in fungal cell wall synthesis. Inhibiting this target disrupts the fungal cell wall. This mechanism underlies its antifungal activity against fungal infections.
Rezafungin is being developed by CorMedix Inc., which trades under the ticker CRMD. CorMedix is the sponsor of the ongoing Phase 3 clinical program evaluating rezafungin in liver transplant patients.
Rezafungin is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program is currently enrolling participants for the liver transplant infection prevention indication.
Rezafungin is being evaluated in the Phase 3 trial NCT06774144, titled Rezafungin Prophylaxis in Liver Transplant. The trial is enrolling by invitation in the United States, with a planned enrollment of 385 adults aged 18 years and older, and uses an active-controlled design.