CRMD REZZAYO Phase III ReSPECT Study Meets Primary Endpoint
CorMedix Inc. announced positive topline results from its global Phase III 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 against standard antimicrobial regimens with 60.7% fungal-free survival at Day 90 for rezafungin versus 59.0% for the standard regimen. Rezafungin was well tolerated, showing a favorable safety profile and reduced drug-drug interactions, positioning it as a potential alternative if approved for an expanded indication. The company plans a pre-NDA meeting with the FDA soon, targeting a supplemental New Drug Application submission in the second half of 2026.
Key Highlights
- REZZAYO Phase III ReSPECT study met primary endpoint for prophylaxis of invasive fungal diseases.
- Study showed non-inferiority vs. standard antimicrobial regimen (SAR) in fungal-free survival at Day 90.
- Fungal-free survival at Day 90 was 60.7% for rezafungin compared to 59.0% for SAR.
- Demonstrated 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 meeting with FDA soon, targeting sNDA submission in 2H26.
- Potential US market opportunity for REZZAYO in prophylaxis exceeds $2 billion.
- REZZAYO has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S.
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