Rezafungin trial met Phase III endpoint, Mundipharma says

Mundipharma said additional Phase III ReSPECT trial results for REZZAYO, or rezafungin acetate, supported its use under study for preventing invasive fungal diseases in adults undergoing allogeneic haematopoietic stem cell transplantation.

The company said the global, multicentre, randomised, double-blind study enrolled 402 patients assigned to rezafungin and 200 assigned to a standard antimicrobial regimen. Mundipharma said the trial met its primary endpoint, showing non-inferiority of rezafungin for fungal-free survival at Day 90 after transplantation.

Fungal-free survival at Day 90 was 60.7% with rezafungin and 59.0% with the standard regimen, corresponding to an estimated treatment difference of 1.6 percentage points, with a 95% confidence interval from -6.2 to 9.3 and P=0.0002 for non-inferiority, the company said.

Mundipharma said proven or probable invasive fungal disease contributing to fungal-free survival failure occurred in 3.5% of patients receiving rezafungin and 4.5% receiving the standard regimen. It said serious adverse events occurred in 66.0% and 67.5% of patients, respectively, and that no new safety signals were identified in allogeneic stem cell transplant recipients.

The company said data from ReSPECT have been submitted to the US Food and Drug Administration and the European Medicines Agency for regulatory review. It said the prophylaxis use studied in ReSPECT is investigational and is not currently approved in the United States or European Union. In the United States, the FDA has granted Priority Review, with a target action date in the first quarter of 2027, Mundipharma said.