CRMD REZZAYO Phase III met primary endpoint for fungal-free survival
CorMedix Inc. announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation. The study met its primary endpoint, demonstrating non-inferiority in fungal-free survival at Day 90 compared to standard antimicrobial regimens (60.7% vs. 59.0%). Rezafungin was well tolerated with a favorable safety profile, particularly regarding toxicity-related discontinuations and drug-drug interactions. The company plans a pre-NDA meeting with the FDA in the coming months, targeting a supplemental New Drug Application (sNDA) submission in 2H26 for an expanded prophylaxis indication, with an estimated US market opportunity exceeding $2 billion.
Key Highlights
- ReSPECT Phase III study met primary endpoint for FDA and EMA, showing non-inferiority in fungal-free survival at Day 90.
- Fungal-free survival at Day 90 was 60.7% for rezafungin compared to 59.0% for standard antimicrobial regimen.
- Study showed favorable benefit for toxicity-related discontinuations and drug-drug interactions.
- Rezafungin was well tolerated, with a safety profile comparable to standard antimicrobial regimens.
- CorMedix anticipates a pre-NDA submission meeting with FDA in coming months, targeting sNDA submission in 2H26.
- REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults.
- CorMedix estimates the potential US market opportunity for REZZAYO in prophylaxis exceeds $2 billion.
- Rezafungin has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S.