Mundipharma announces patient enrolment completion in Phase III ReSPECT clinical trial for REZZAYO® (rezafungin)

For Trade and Medical Media Only

• Enrolment completed in Phase III ReSPECT study in prophylaxis of fungal infections in adult patients undergoing allogeneic blood and marrow transplant
• Topline results from ReSPECT study expected by mid-2026

Mundipharma today announced completion of patient enrolment for the ongoing, global Phase III ReSPECT trial evaluating REZZAYO^® (rezafungin).

The ReSPECT trial is a global, randomised, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic blood and marrow transplantation.

“Completing patient enrolment for the Phase III ReSPECT study marks a key milestone in addressing the unmet need for antifungal prevention in immunosuppressed patients,” said Dr Yuri Martina, Chief Development and Medical Officer at Mundipharma. “Patients have enrolled in this global study from more than 50 clinical trial centres across seven countries. We look forward to the clinical evidence that this study will produce.”

*ENDS*

About invasive candidiasis

Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems.^1,2 Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%.^2,3 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.⁴

About rezafungin

Rezafungin is indicated for the treatment of invasive candidiasis in adults.⁵

REZZAYO^® is a registered trademark of NAPP Pharmaceutical Group Limited a member of the Mundipharma network.

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. For more information visit www.mundipharma.com.

Commercialisation rights to rezafungin in the United States are licensed to CorMedix Inc.

References:

1. Cortegiani A, et al. Cochrane Database Syst Rev 2016;1:CD004920
2. Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56
3. Bassetti M, et al. Crit Care 2019;23(1):219
4. Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed October 2025)
5. REZZAYO^®Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15479/smpc#gref (last accessed October 2025)

Job code: GBL-S-RZF-2500016
Date of preparation: October 2025

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