CorMedix Announces Phase III Results from ReSPECT Trial
CorMedix announced Phase III topline results from the global ReSPECT clinical trial evaluating Rezzayo for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation. The ReSPECT Phase III study, one of the largest anti-fungal multicenter, randomized, double-blind studies evaluated the efficacy and safety of once weekly rezafungin compared with a standard antimicrobial regimen for the prophylaxis of invasive fungal diseases, including infections caused by Candida, Aspergillus, and Pneumocystis, in adults undergoing allogeneic HSCT. Patients undergoing allogeneic blood and marrow transplantation face prolonged periods of immunosuppression and routinely require extended antifungal prophylaxis, representing a setting where differentiated dosing, improved side effect profile, and reduced DDI is beneficial, and comparable efficacy is expected. The ReSPECT study met its primary endpoint for FDA and EMA for fungal-free survival at Day 90 showing non-inferiority vs. SAR, with 60.7% fungal-free survival at Day 90 for rezafungin compared to 59% for standard antimicrobial regimen. This demonstrates that rezafungin's differentiated pharmacokinetics/pharmacodynamics profile was comparable to the standard antimicrobial regimen in reducing the incidence of invasive fungal infections in a high-risk patient population. Rezafungin was well tolerated, with a safety profile showing a favorable benefit/risk profile for immunocompromised patients. The Phase III study topline results demonstrated comparable efficacy against invasive infections from candida, aspergillus and pneumocystis in both therapeutic arms, as well as comparable mortality. In addition, results showed a favorable profile in multiple secondary endpoints, most notably treatment emergent adverse events leading to dose reduction, interruption or withdrawal of study drug, and treatment emergent adverse events leading to study discontinuation. The companies anticipate a pre-NDA submission meeting with FDA in the coming months, followed by a target submission of a supplemental New Drug Application to the FDA in 2H26 based on the ReSPECT results.
