CAMBRIDGE, ENGLAND -- Mundipharma announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO® (rezafungin acetate) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT).

The ReSPECT Phase III trial, one of the largest antifungal, multicentre, randomised, double-blind studies evaluated the efficacy and safety of once weekly rezafungin compared with a SAR for the prophylaxis of IFDs, including infections caused by Candida, Aspergillus, and Pneumocystis, in adults undergoing allogeneic HSCT. Patients undergoing allogeneic HSCT face prolonged periods of immunosuppression and routinely require extended antifungal prophylaxis,[1] 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 US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards for fungal-free survival at Day 90, showing non-inferiority of rezafungin vs. SAR (60.7% vs. 59.0%, respectively). This demonstrates that rezafungin’s differentiated pharmacokinetics/pharmacodynamics (PK/PD) profile was comparable to the SAR in reducing the incidence of invasive fungal diseases in a high-risk patient population. Rezafungin was well tolerated, with a safety profile showing a favourable benefit/risk profile for immunocompromised patients.

The Phase III study topline results indicate comparable efficacy against invasive infections from Candida, Aspergillus and Pneumocystis in both therapeutic arms, as well as comparable mortality. In addition, results showed a favourable profile in multiple secondary endpoints, most notably treatment-emergent adverse events leading to dose-reduced interruption or withdrawal of study drug, and treatment-emergent adverse events leading to study discontinuation.

“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,” said Dr. Yuri Martina, Chief Development & Medical Officer at Mundipharma. “These findings represent a meaningful step forward in advancing care for this vulnerable population. Rezafungin holds the potential to change the standard of care for these patients.”

Mundipharma and its US licensee, CorMedix currently intend to target submission of a supplemental New Drug Application (sNDA) to the FDA in 2H26 based on the ReSPECT results. Mundipharma expects an EMA submission in Q3, 2026.