CorMedix Therapeutics (Nasdaq: CRMD) saw its shares climb after announcing positive topline results from a pivotal Phase III study of its antifungal drug, REZZAYO® (rezafungin), which met its primary endpoint for preventing invasive fungal diseases in high-risk transplant patients.
"We believe this positive outcome of the Phase III ReSPECT study meaningfully strengthens REZZAYO’s long-term potential value proposition to patients and clinicians," said Joseph Todisco, Chairman & Chief Executive Officer of CorMedix Therapeutics. "Preliminary topline results for ReSPECT demonstrate clinical efficacy in prevention against all three measured pathogens, as well as positive differentiation in certain safety related secondary endpoints."
The global ReSPECT trial demonstrated that rezafungin was non-inferior to the standard antimicrobial regimen, with a fungal-free survival rate of 60.7% at Day 90 for the rezafungin arm, compared to 59.0% for the control arm. The drug also showed a favorable safety profile, with fewer treatment discontinuations due to toxicity and reduced drug-drug interactions.
The results pave the way for CorMedix to seek an expanded indication for rezafungin, which is already approved for treating candidemia and invasive candidiasis. The company is targeting a supplemental New Drug Application (sNDA) submission in the second half of 2026, aiming to enter a US prophylaxis market it estimates to be worth over $2 billion.
Trial Details and Safety Profile
The ReSPECT study was a multicenter, randomized, double-blind trial evaluating once-weekly rezafungin against a standard daily regimen for prophylaxis against infections caused by Candida, Aspergillus, and Pneumocystis. This patient population is highly immunosuppressed and requires extended antifungal prophylaxis, a setting where a well-tolerated, once-weekly dosing schedule could offer a significant advantage.
Beyond meeting the primary non-inferiority endpoint, the study highlighted key secondary benefits. Rezafungin showed a favorable profile regarding treatment emergent adverse events that led to dose reduction, interruption, or withdrawal of the study drug. Mortality rates were comparable between the two arms.
Path to Expanded Approval
CorMedix, which holds the U.S. commercial rights through its subsidiary Melinta Therapeutics, plans to request a pre-NDA meeting with the Food and Drug Administration (FDA) in the coming months. The trial, sponsored by Mundipharma which holds rights outside the U.S., provides the foundation for this regulatory push.
Rezafungin, a next-generation echinocandin, has orphan drug exclusivity through 2035 and patent coverage until 2038 in the U.S., providing a long runway for commercialization if the expanded indication is approved. The current mortality rate for invasive candidiasis can be as high as 40%, underscoring the need for effective and well-tolerated treatment and prevention options.
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