CorMedix (CRMD) announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation. This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix. The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin versus a standard antimicrobial regimen for the prevention of invasive fungal diseases in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities.
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