At IDWeek 2025, (the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists) held from 19 to 22 October in Atlanta, Georgia, investigators presented results from three Phase I studies evaluating EL219 (formerly SF001), a novel, next-generation polyene antifungal developed by Elion Therapeutics. Across single and multiple-ascending-dose cohorts and a renal-impairment study, EL219 was well-tolerated and showed no clinically meaningful renal toxicity, including in adults with moderate renal impairment.
Invasive fungal infections (IFIs) continue to rise globally, driven by an expanding immunocompromised population and increasing use of immunosuppressive therapies. While amphotericin B (AmB) remains a cornerstone for treatment, its use is limited by nephrotoxicity and the need for daily dosing. EL219 is a structurally modified AmB derivative designed to improve selectivity for fungal sterols over mammalian cholesterol, aiming to preserve AmB’s broad-spectrum efficacy while minimising renal toxicity.
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EL219 demonstrated dose-proportional pharmacokinetics and a prolonged half-life exceeding 60 hours, supporting potential once-weekly intravenous administration. No dose adjustments were required for participants with moderate renal impairment.
In the current antifungal landscape, emerging agents such as olorofim and fosmanogepix employ novel mechanisms of action, whereas EL219 remains within the polyene family, offering clinicians a familiar mechanism with an improved safety margin. Investigators anticipate that EL219 could slot into early antifungal therapy for suspected mould infections and serve as a first-line option where existing AmB formulations are contraindicated due to renal risk.
Elion’s next steps include a Phase II study in cryptococcal meningitis and further renal cohorts, with EL219 positioned to expand polyene use in IFI management through safer, longer-acting dosing.
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