CorMedix (NASDAQ:CRMD) announced positive topline results on Monday from the global Phase III ReSPECT trial evaluating REZZAYO (rezafungin) for the prevention of invasive fungal diseases in adult allogeneic hematopoietic stem cell transplant (HSCT) patients.
The study successfully met its primary endpoint, establishing rezafungin’s non-inferiority to the current standard antimicrobial regimen.
The trial, sponsored by Mundipharma, revealed a fungal-free survival rate of 60.7% for the rezafungin arm at Day 90, compared to 59% for the control group.
Beyond meeting the primary benchmark, the data indicated that rezafungin provided comparable efficacy across key fungal threats, including Candida, Aspergillus, and Pneumocystis.
Mortality rates were also found to be comparable between the two treatment arms.
A significant highlight of the study was Rezzayo’s favorable safety and tolerability profile.
Patients treated with rezafungin experienced fewer toxicity-related discontinuations and a marked reduction in drug-drug interactions compared to those on the standard-of-care regimen.
These factors are particularly critical for HSCT patients, who typically require complex, multi-drug treatment plans that are often complicated by the side effects of traditional antifungals.
Following these successful results, CorMedix and its partners are preparing for a pre-NDA meeting with the U.S. Food and Drug Administration.
The company currently targets a supplemental New Drug Application (sNDA) submission in the second half of 2026.
If approved for this expanded indication, Rezzayo could offer a simplified, once-weekly dosing alternative to daily antifungal prophylaxis for one of the most vulnerable patient populations in oncology.