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CorMedix Announces Completion of Enrollment in Phase III ReSPECT Clinical Trial for REZZAYO
Globenewswire· 2025-09-29 12:30
Core Insights - CorMedix Inc. has completed enrollment for the Phase III ReSPECT trial, which evaluates the efficacy of REZZAYO® (rezafungin) in preventing fungal infections in adult patients undergoing allogeneic blood and marrow transplantation (BMT) [1][2] - Topline results from the ReSPECT study are expected in the second quarter of 2026, which is a significant milestone towards seeking FDA approval for REZZAYO in this indication [2][5] - The ReSPECT trial is a multicenter, randomized, double-blind study comparing once-weekly rezafungin to a standard antimicrobial regimen, with the primary endpoint being fungal-free survival at day 90 [2][3] Company Overview - CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases, including antifungal treatments [4] - Following the acquisition of Melinta Therapeutics in August 2025, CorMedix is expanding its portfolio to include various anti-infective products alongside REZZAYO [4][5] - REZZAYO is already approved in the U.S. for treating candidemia and invasive candidiasis, with an estimated addressable market of approximately 130,000 patients for antifungal prophylaxis, translating to a total addressable market of over $2 billion [3][4] Product Details - REZZAYO (rezafungin) is a next-generation echinocandin indicated for patients with limited treatment options for candidemia and invasive candidiasis [3][7] - The drug has orphan drug exclusivity until 2035 and patent coverage until 2038 in the U.S., enhancing its market potential [3]