CorMedix Inc. has completed enrollment in its pivotal Phase III ReSPECT clinical trial evaluating REZZAYO (rezafungin) for the prevention of invasive fungal infections in adults undergoing allogeneic blood and marrow transplantation (BMT). The milestone positions the biopharmaceutical company to advance toward potential FDA approval for a prophylaxis indication that could address a significant unmet medical need in this high-risk patient population.
The global, multicenter trial is sponsored by Mundipharma in the United Kingdom, with CorMedix holding U.S. distribution rights through its strategic collaboration with Melinta Therapeutics, a wholly owned subsidiary acquired in August 2025. Topline results from the study are expected in the second quarter of 2026.
Clinical Trial Design and Endpoints
The ReSPECT study is a randomized, double-blind Phase III trial comparing the efficacy and safety of once-weekly rezafungin against a standard antimicrobial regimen (SAR) for preventing invasive fungal diseases in adults undergoing allogeneic BMT. The trial specifically targets prevention of Candida, Aspergillus, and Pneumocystis infections.
Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly doses for 13 weeks, along with oral placebos matching the standard antimicrobial regimen components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of invasive fungal disease, discontinuation due to toxicity, and mortality adjusted for comorbidities.
Market Opportunity and Commercial Potential
REZZAYO represents a substantial commercial opportunity for CorMedix in the antifungal prophylaxis market. The company estimates approximately 130,000 patients constitute the addressable market for antifungal prophylaxis in the United States, with an implied total addressable market exceeding $2 billion in this segment.
"Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT," said Joseph Todisco, CEO of CorMedix. "We believe that a prophylaxis indication for REZZAYO represents a significant growth opportunity for CorMedix, given the critical unmet need in this high-risk patient population."
Current Therapeutic Profile
REZZAYO is a next-generation echinocandin currently approved in the United States for treating candidemia and invasive candidiasis in adults aged 18 years and older who have limited or no alternative treatment options. The drug addresses an estimated 50,000 cases of candidemia and invasive candidiasis annually in the United States.
The therapeutic maintains orphan drug exclusivity through 2035 and patent coverage through 2038 in the United States, providing substantial market protection for the potential prophylaxis indication. Current approval is based on limited clinical safety and efficacy data, and the drug has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
Safety Profile and Administration
Clinical trial data indicate that REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. The drug is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Additional safety considerations include potential photosensitivity and abnormalities in liver function tests.
The most common adverse reactions with an incidence of 5% or greater include hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Healthcare providers are advised to monitor patients who develop abnormal liver tests and evaluate the risk-benefit profile of continuing therapy.
Strategic Portfolio Integration
Following CorMedix's recent acquisition of Melinta Therapeutics, REZZAYO joins a comprehensive portfolio of anti-infective products including MINOCIN (minocycline), VABOMERE (meropenem and vaborbactam), ORBACTIV (oritavancin), BAXDELA (delafloxacin), and KIMYRSA (oritavancin). The company also commercializes DefenCath (taurolidine and heparin) for preventing catheter-related bloodstream infections in hemodialysis patients.
The completion of ReSPECT trial enrollment marks a critical advancement in CorMedix's strategy to expand REZZAYO's therapeutic applications beyond its current treatment indication to include prophylaxis in the vulnerable BMT patient population, where invasive fungal infections represent a significant cause of morbidity and mortality.
