CorMedix Phase III Trial Shows 60.7% Fungal-Free Survival Versus 59.0% Regimen
The ReSPECT Phase III trial in allogeneic HSCT patients met its primary endpoint with rezafungin achieving 60.7% fungal-free survival at Day 90 versus 59.0% for standard antimicrobials. Rezafungin showed fewer toxicity-related discontinuations and reduced drug-drug interactions with a safety profile comparable to the standard regimen.
1. Trial Design and Primary Endpoint
The global, randomized, double-blind ReSPECT Phase III trial evaluated once-weekly rezafungin versus a standard antimicrobial regimen for prophylaxis of Candida, Aspergillus, and Pneumocystis infections in adults undergoing allogeneic HSCT, meeting its non-inferiority primary endpoint with 60.7% versus 59.0% fungal-free survival at Day 90.
2. Safety and Secondary Endpoint Findings
Rezafungin demonstrated a comparable safety profile to the standard regimen with a favorable reduction in treatment-emergent adverse events leading to dose reductions, interruptions or withdrawals, as well as fewer drug-drug interactions in immunocompromised patients.
3. Regulatory Pathway and Market Potential
CorMedix plans a pre-NDA meeting with FDA ahead of a supplemental NDA submission in 2H 2026, leveraging orphan drug exclusivity through 2035 and patent coverage until 2038, and targeting a US prophylaxis market opportunity estimated to exceed $2 billion with US distribution through Melinta and ex-US rights via Mundipharma.