Rezafungin Meets Primary Endpoint in Study
On April 27, Mundipharma announced the positive results of its Phase III ReSPECT trial, which evaluated the prophylactic efficacy of rezafungin against invasive fungal diseases in adults undergoing allogeneic haematopoietic stem cell transplantation. This trial stands out as one of the largest antifungal, multicentre, randomised, double-blind studies to date.
Meeting its primary endpoint, the trial demonstrated that rezafungin is non-inferior to standard antimicrobial regimens, achieving a fungal-free survival rate of 60.7% at Day 90 compared to 59.0% for standard treatments. These findings highlight comparable efficacy in the prevention of invasive fungal diseases.
Dr. Yuri Martina, the Chief Development & Medical Officer at Mundipharma, expressed enthusiasm about the trial’s outcomes, noting, “We are very excited by the study results, which met all its endpoints, and reflect the contribution of patients enrolled across more than 50 centres in seven countries.”
Advantages of Rezafungin
With a safety profile akin to standard regimens, rezafungin was well tolerated. The trial underscored its benefits, such as reduced drug-drug interactions and fewer toxicity-related discontinuations, essential for immunocompromised patients receiving stem cell transplants.
The ReSPECT trial also showcased a favorable outcome in several secondary endpoints. Particularly, there was a reduction in treatment-emergent adverse events that led to dose-reduced interruptions or withdrawals of the study drug.
Effective against invasive infections from Candida, Aspergillus, and Pneumocystis, the study reported similar mortality rates between the therapeutic groups. These results support rezafungin’s potential as a standard care for preventing invasive fungal diseases.
Mundipharma plans to file a supplemental New Drug Application (sNDA) with the FDA in the second half of 2026 and expects an EMA submission in the third quarter of the same year. These submissions aim to broaden rezafungin’s use as a prophylactic treatment.
Currently, rezafungin is approved for treating candidaemia and invasive candidiasis. The success of the ReSPECT trial could significantly expand its application, enhancing care for patients undergoing stem cell transplants who endure extended periods of immunosuppression.
According to the trial data, patients undergoing allogeneic HSCT face prolonged immunosuppression, necessitating effective antifungal prophylaxis. Rezafungin’s differentiated pharmacokinetics/pharmacodynamics profile was comparable to standard treatments in reducing invasive fungal infections among this high-risk group.
Last updated: 28 April 2026, 1:19 am
