EL219 for Fungal Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, EL219 (a potential antifungal drug), to determine its safety and effectiveness for individuals with early signs of serious fungal infections, particularly those at risk due to weakened immune systems or recent medical treatments like bone marrow transplants. Participants will receive either the new treatment or the current standard antifungal treatment to compare their effects. It suits those who have had a bone marrow transplant, are on immune-suppressing medications, or have an inherited immune deficiency and suspect a fungal infection. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot use certain medications known to interact with voriconazole, like terfenadine and rifampin. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that EL219 is likely to be safe for humans?
Research has shown that EL219 was well-tolerated in past studies. Tests with various doses and patient groups, including those with kidney problems, revealed no safety concerns. EL219 remains in the body longer, enabling once-a-week dosing. This new antifungal treatment did not cause any serious side effects. Overall, the safety results appear promising based on the current data.12345
Why do researchers think this study treatment might be promising for fungal infection?
Researchers are excited about EL219 for treating fungal infections because it offers a potentially more efficient and targeted approach compared to standard treatments like Liposomal Amphotericin B (LAmB) and voriconazole. EL219 is administered via IV infusion in specific dosing intervals that could improve treatment outcomes by maintaining consistent therapeutic levels in the body. Additionally, its unique formulation might reduce the side effects often associated with standard antifungal therapies, such as kidney toxicity. This innovative treatment approach aims to provide a safer and possibly more effective option for patients battling fungal infections.
What evidence suggests that EL219 might be an effective treatment for fungal infection?
Research has shown that EL219, which participants in this trial may receive, holds promise for treating fungal infections. In studies, EL219 extended patients' lives and reduced lung fungus, indicating its potential effectiveness against fungal infections. Importantly, EL219 is generally safe, with most side effects being mild. These findings suggest it could become a new treatment option for serious mold infections.12356
Who Is on the Research Team?
Taylor G. Sandison, MD
Principal Investigator
Sponsor: Elion Therapeutics, Chief Medical Officer
Are You a Good Fit for This Trial?
This trial is for adults with severe immunodeficiency or those who have had recent bone marrow transplants, are on certain immunosuppressants, or corticosteroids. Participants must show early signs of a fungal infection but not meet full criteria for invasive aspergillosis and need to have IV access. Those recently treated for hematological malignancy can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either EL219 or standard of care antifungal therapy. EL219 group receives a loading dose on Day 1 and subsequent doses on Days 8, 15, 22, 29, and 36. Standard of care group receives LAmB for 14-42 days and voriconazole thereafter.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including all-cause mortality and adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- EL219
Trial Overview
The study compares the safety and effectiveness of a new antifungal drug called EL219 against standard antifungal treatments in patients showing early signs of suspected invasive mould infections.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to EL219 will receive a single loading dose of EL219 at 2 mg/kg via IV infusion on Day 1, and 1.5 mg/kg IV infusions on Days 8, 15, 22, 29, and 36. All dosing calculations for EL219 will be based on total body weight (TBW). To maintain the blind, placebo IV infusions will be administered to participants randomized to EL219 arm daily (corresponding to Liposomal Amphotericin B (LAmB) dosing); or 2x daily (corresponding to voriconazole dosing depending on the Investigator's choice of Comparator).
Comparator arm (CMPTR) will receive LAmB 3mg/kg once daily IV infusions for min.14 days \& up to 42 days. Participants w/suspected or diagnosed mucormycosis may be dosed at 5mg/kg. Voriconazole (Vori) 6mg/kg BID IV loading dose on Day 1 followed by 4mg/kg IV BID thereafter. Dosing calculations for LAmB \& vori are based on TBW. Participants may switch from CMPTR to optional SOC antifungals (PI discretion) if any of these occur: Toxicity; serum creatinine 2×baseline (bsln) level or 50% reduction in GFR, Hypokalemia or hypomagnesemia not controlled with IV supplementation, increase in ALT to 3×bsln and/or total bili 3×bsln, intractable IRR •Imminent hosp discharge requiring switch from CMPTR •Intolerable clinical s/s consistent w/known drug-related effect •Dx by C\&S testing suggesting IMI not appropriately treated w/1 or both CMPTR drug Vori trough level \<2.0 or \>5.5mg/L for whom vori was selected as the randomized CMPTR
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elion Therapeutics, Inc.
Lead Sponsor
Citations
Efficacy assessments of EL219, a next-generation polyene ...
EL219 demonstrated broad-spectrum efficacy, improved survival, and reduced lung fungal burden, supporting its potential as a novel therapy for ...
Study of EL219 vs Standard of Care for Early Antifungal ...
The purpose of this study is to determine if EL219 is safe and effective compared to the standard of care for early treatment of suspected invasive mould ...
3.
eliontx.com
eliontx.com/wp-content/uploads/2025/11/Sandison_GAMRIC-25-EL219-safety-and-PK_poster_Final.pdfEL219, a novel next-generation, once-weekly polyene ...
Across all three studies: — There were no deaths or serious AEs. — Most TEAEs were mild IRRs at doses of >1.5 mg/kg, all of which resolved.
4.
clinicaltrialsarena.com
clinicaltrialsarena.com/analyst-comment/idweek-2025-el219-safety-pk-profile-phase-i-studies/EL219 shows favourable safety and PK profile in Phase I ...
Across single and multiple-ascending-dose cohorts and a renal-impairment study, EL219 was well-tolerated and showed no clinically meaningful ...
5.
ctv.veeva.com
ctv.veeva.com/study/study-of-el219-vs-standard-of-care-for-early-antifungal-therapy-of-suspected-invasive-mould-infectioStudy of EL219 vs Standard of Care for Early Antifungal ...
The purpose of this study is to determine if EL219 is safe and effective compared to the standard of care for early treatment of suspected ...
6.
eliontx.com
eliontx.com/wp-content/uploads/2025/09/Sandison-TIMM-25-EL219-safety-poster_A0_FOR-PRINT.pdfSafety of EL219 (SF001) in Phase 1 dose-escalation and ...
— EL219 is in clinical development for early antifungal therapy of suspected pulmonary mould infections, treatment of invasive aspergillosis, ...
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