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CorMedix Therapeutics Announces Positive Topline Results from Phase III ReSPECT Trial Assessing REZZAYO® for the Prophylaxis of Invasive Fungal Diseases in Allogeneic Hematopoietic Stem Cell Transplantation Patients
– The study primary endpoint was met, showing non-inferiority vs. standard antimicrobial regimen in fungal free survival at Day 90 – – Study showed favorable
About this update from Cormedix Inc.
[{"type":"text","content":"– The study primary endpoint was met, showing non-inferiority vs. standard antimicrobial regimen in fungal free survival at Day 90 – – 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 – PARSIPPANY, N.J., April 27, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO® (rezafungin for injection) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). 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 (rezafungin acetate) compared with a standard antimicrobial regimen (SAR) 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 59.0% for standard antimicrobial regimen. This demonstrates that rezafungin’s differentiated pharmacokinetics/pharmacodynamics (PK/PD) profile was comparable to the standard antimicrobial regimen (SAR) 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 dos...