Mundipharma reports Phase III ReSPECT trial results showing REZZAYO (rezafungin) achieves non-inferiority in preventing invasive fungal infections in HSCT patients.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Mundipharma has reported positive topline results from the Phase III ReSPECT trial (NCT04368559) evaluating once-weekly rezafungin (REZZAYO®) for prophylaxis of invasive fungal diseases (IFDs) in adults undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
This global, multicenter, randomized, double-blind study compared rezafungin against a standard antifungal regimen in a high-risk population with prolonged immunosuppression. The trial successfully met its primary endpoint of fungal-free survival at Day 90, aligning with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) criteria.
Rezafungin demonstrated non-inferiority to the comparator, with fungal-free survival rates of 60.7% versus 59.0%. Efficacy was comparable across arms for infections due to Candida, Aspergillus, and Pneumocystis species, accompanied by similar mortality rates.
The drug was generally well tolerated, showing a favorable safety profile with fewer treatment-emergent adverse events leading to dose interruption or discontinuation compared to the standard regimen.
These results reinforce rezafungin’s potential in high-risk settings requiring extended antifungal prophylaxis. Already FDA-approved as a next-generation echinocandin for candidaemia and invasive candidiasis in immunocompromised patients, rezafungin addresses conditions linked to high mortality.
Mundipharma and U.S. licensee CorMedix plan a supplemental New Drug Application (sNDA) submission to the FDA in H2 2026, followed by an EMA filing in Q3 2026.
Dr. Yuri Martina, Chief Development & Medical Officer at Mundipharma noted that the study met all endpoints, crediting contributions from patients across more than 50 centers in seven countries and underscoring its support for further development in this population.
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About the Writer
Sana Jamil Khan is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.