Mundipharma announces positive topline results from Phase III ReSPECT trial assessing ▼REZZAYO® (rezafungin) for the prophylaxis of invasive fungal diseases in allogeneic haematopoietic stem cell transplantation patients

(BUSINESS WIRE) -- Mundipharma today 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.

About rezafungin

Rezafungin is a next-generation echinocandin approved for the treatment of candidaemia and invasive candidiasis in adults.² Invasive candidiasis continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%.^3,4

Rezafungin has been studied for the prophylaxis of invasive fungal diseases in adults undergoing allogeneic HSCT.

Approximately 1.3 million people worldwide were diagnosed with haematological malignancies in 2019,⁵ the majority of whom are at risk of treatment‑related neutropenia, leaving them highly vulnerable to invasive fungal infections and underscoring the ongoing unmet need for effective antifungal prophylaxis.

® REZZAYO is a Registered Trademark of Mundipharma, used under licence by Melinta Therapeutics LLC, a wholly owned subsidiary of CorMedix Inc. in the USA.

About Mundipharma

Mundipharma is a global healthcare company with a presence in Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East. In line with its mission, United for Patients, Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease, ophthalmology, oncology, respiratory and central nervous system.

References:

1. M Quattrone et al. Managing invasive fungal infections during allogeneic hematopoietic transplantation: a 2025 update. Mediterranean Journal of Hematology and Infectious Diseases. 2025;17(1):e2025064. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12422250/ (last accessed April 2026)

2. REZZAYO^® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15479/smpc#gref (last accessed April 2026)

3. M Bassetti et al. Incidence and outcome of invasive candidiasis in intensive care units (ICUs) in Europe: results of the EUCANDICU project. Critical Care. 2019;23(1):219. Available at: https://pubmed.ncbi.nlm.nih.gov/31200780/ (last accessed April 2026)

4. A Cortegiani et al. Antifungal agents for preventing fungal infections in non‑neutropenic critically ill patients. The Cochrane Database of Systematic Reviews. 2016;(1):CD004920. Available at: https://pubmed.ncbi.nlm.nih.gov/26772902/ (last accessed April 2026)

5. N Zhang et al. Global burden of hematologic malignancies and evolution patterns over the past 30 years. Blood Cancer Journal. 2023:13(1):82. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10188596/pdf/41408_2023_Article_853.pdf (last accessed April 2026)

Job Code: GBL-S-RZF-2600002 
Date of preparation: April 2026

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