EL219 for Fungal Infection

Overseen By Gordana Schnider, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Elion Therapeutics, Inc.

Must not be taking: Voriconazole, Protease inhibitors, Barbiturates, others

Disqualifiers: Heart failure, Dialysis, Liver cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 42 days

80 Participants Needed

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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

I am willing and able to sign the consent form.

I am 18 years old or older.

I have received a bone marrow transplant from another person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

42 days

6 visits (in-person) for EL219 group, variable for standard of care group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including all-cause mortality and adverse events.

4 weeks

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?

Group I: EL219 Experimental Treatment 1 Intervention

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. To maintain the blind, placebo IV infusions will be administered on Days 2-7 and 9-14 corresponding to Liposomal Amphotericin B (LAmB) dosing; thereafter, twice daily oral or IV placebo will be administered corresponding to voriconazole dosing until Day 42/EOT.

Group II: Antifungal Comparator Active Control 1 Intervention

Standard of Care- Participants will receive LAmB 3 mg/kg IV infusions for at least 14 days and up to 42 days.Voriconazole Daily Dosing- Loading 6 mg/kg via IV infusion every 12 hrs for the first 24 hrs. Post-loading: 4 mg/kg oral every 12 hrs (admin as 50 mg overencapsulated tabs) OR 4 mg/kg via IV infusion every 12 hrs Participants on oral therapy will be administered placebo IV infusions corresponding to EL219 on Days 15, 22, 29, and 36 to maintain the blind. Participants may switch from LAmB to voriconazole (oral or IV) at any time, if any of the following occur: * Dx. of proven or probable IA per EORTC/MSG criteria * Other proven or probable susceptible MI * Possible IMI that requires continued antifungal therapy * Toxicity: Acute renal injury, hypokalemia or hypomagnesemia uncontrolled with IV supplementation, Increase in ALT to 3× baseline and/or total serum bilirubin 3× baseline, Intractable IRR * Change to oral due to imminent hosp. discharge

Who Is Running the Clinical Trial?

Elion Therapeutics, Inc.

Lead Sponsor

Citations

1.

journals.asm.org

journals.asm.org/doi/10.1128/aac.01400-25

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 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07215273

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.pdf

EL219, 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-infectio

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 ...

6.

eliontx.com

eliontx.com/wp-content/uploads/2025/09/Sandison-TIMM-25-EL219-safety-poster_A0_FOR-PRINT.pdf

Safety 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, ...