In short
EL219 is an investigational antifungal medicine being studied for early treatment of suspected invasive mould infections (IMIs), a serious type of fungal infection. It is a chemically modified form of amphotericin B, a well-known antifungal drug. One Phase 2 clinical trial is currently authorised, comparing EL219 against liposomal amphotericin B or voriconazole in 60 participants.
EL219 is an investigational antifungal medicine being studied for early treatment of suspected invasive mould infections (IMIs), a serious type of fungal infection. The full chemical name is N38-(1,3-DIHYDROXYPROPAN-2-YL)-2'-EPI-AMPHOTERICIN B-38-AMIDE. It is a chemically modified form of amphotericin B, a well-known antifungal drug. One Phase 2 clinical trial is currently authorised, comparing EL219 against liposomal amphotericin B or voriconazole in 60 participants.
The information on this page comes from the EU Clinical Trials Information System (CTIS) record for this trial, identified as NCT07215273.
Key points
- EL219 is an investigational antifungal derived from amphotericin B.
- The trial studies suspected invasive mould infection, a life-threatening fungal condition.
- The study is in Phase 2 and has been authorised to begin.
- 60 participants are planned to take part.
- EL219 is given intravenously at a dose of 2 mg per kilogram.
- The trial compares EL219 with liposomal amphotericin B or voriconazole.
What is EL219?
EL219 is an investigational antifungal medicine. It is a chemically modified version of amphotericin B, a drug that has been used for decades to treat serious fungal infections. The modification is designed to create a new molecule with potentially different properties from the original amphotericin B. EL219 is not yet authorised as a medicine; it is being studied in clinical trials. The substance is given intravenously in the trial.
How does EL219 work?
The trial record does not describe the mechanism of action of EL219 in detail. As a derivative of amphotericin B, it belongs to the polyene class of antifungals, but the specific molecular target of EL219 is not stated in the registry data. The trial is designed to evaluate its efficacy and safety compared with existing antifungal treatments.
Which conditions is it used or studied for?
- Suspected invasive mould infection (IMI) — a serious infection caused by moulds that have invaded body tissues. The trial treats patients in whom such an infection is suspected but not yet confirmed, allowing early antifungal therapy to begin.
How is EL219 given?
EL219 is given by intravenous use, meaning it is administered directly into a vein. In the trial, the dose is 2 mg per kilogram of body weight. The trial also uses a matching placebo of dextrose 5% for blinding purposes, so that participants and researchers do not know which treatment is being given.
What do the clinical trials show?
There is one clinical trial of EL219 registered in the EU Clinical Trials Information System. It is a Phase 2 interventional study, authorised but not yet reported as completed. The trial plans to enrol 60 participants with suspected invasive mould infection. The study compares EL219 against liposomal amphotericin B or voriconazole for early antifungal therapy. The trial is randomised and blinded, with a placebo used to maintain blinding. Results are not yet available, so the trial does not yet show efficacy or safety outcomes.
What is measured in the trial?
The trial has two primary outcomes. The first is all-cause mortality at Day 21, with a window of plus or minus three days, measured in the intent-to-treat analysis set. The second is the occurrence of serious adverse events and treatment-emergent adverse events during the blinded portion of the study, categorised in a tiered approach. Tier 1 events include renal, electrolyte, hepatic, infusion-related reactions, photophobia, and photosensitivity. Tier 2 includes all other treatment-emergent adverse events.
Who can take part in the trial?
The trial enrols participants with suspected invasive mould infection who are suitable for early antifungal therapy. The registry record does not provide detailed inclusion or exclusion criteria beyond the condition itself. The planned enrolment is 60 participants.
What side effects are known?
The trial record does not report side effects of EL219 from completed studies, as the trial has not yet reported results. The trial is designed to collect safety information, including serious adverse events and treatment-emergent adverse events, with particular attention to renal, electrolyte, hepatic, infusion-related reactions, photophobia, and photosensitivity.