RecruitingPHASE2INTERVENTIONAL

Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy

This research study, called EL219, is looking into a new treatment for severe mould infections. These infections can be very serious, especially for people whose immune systems are not working properly, such as those who have had transplants or certain types of cancer. The study aims to find out if EL219 is both safe and effective when compared to two commonly used medicines, liposomal amphotericin B or voriconazole. Participants will be given either the new medicine or one of the standard treatments. By comparing them, doctors hope to understand if EL219 could be a good new option for treating these challenging infections. This is a Phase 2 study, meaning it's an important step in testing new medicines before they can become widely available.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Elion Therapeutics, Inc.

Enrolment target

Start

13 Feb 2026

Estimated completion

01 Dec 2026

Invasive Mould Infection

What is this study about?

This study is about finding better ways to treat a serious health problem called invasive mould infection. Mould infections can be very dangerous, particularly for people with weakened immune systems. This might include individuals who have had organ transplants, have certain blood cancers, or are taking medicines that reduce their body's ability to fight off germs.

Currently, doctors use medicines like liposomal amphotericin B or voriconazole to treat these infections. This study is testing a new medicine, EL219, to see if it could be another effective and safe option. By carefully comparing EL219 to the existing treatments, researchers hope to learn if it works just as well, or even better, and if it has similar or fewer side effects.

Finding new and effective treatments for mould infections is really important because they can be life-threatening. This study is a key step in developing new medicines that could help more people recover from these serious illnesses. It's called a 'Phase 2' study, which means it's one of the earlier stages of testing new drugs, focusing on safety and whether the medicine shows promise.

Key takeaways

This study tests a new medicine (EL219) for serious mould infections.
It compares EL219 to standard treatments (LAmB or voriconazole).
It's for adults with weakened immune systems and a suspected/confirmed mould infection.
The study aims to see if EL219 is safe and effective.
Participation involves receiving medication intravenously and regular check-ups.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, regardless of your gender or background. A key requirement is that you must have a weakened immune system, which puts you at a higher risk for these types of fungal infections. This could be due to having a blood or bone marrow transplant, certain active blood cancers, a very low white blood cell count for a long time, or taking strong medicines like steroids or other treatments that suppress your immune system.

Another important factor is that you must either have a suspected or confirmed mould infection. Doctors will check for this using specific medical tests that are approved in the UK. These might include blood tests, samples from your lungs, or certain imaging scans like a CT scan of your chest that show signs of infection. If a CT scan is used to check if you're eligible, it needs to have been done within 7 days before you officially join the study.

Finally, you must be willing to provide your informed consent, which means you understand what the study involves and agree to take part. You also need to be able to have medicine given to you through a drip into your vein (intravenous access) and be prepared to follow all the study instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a condition or are you taking medicine that weakens your immune system?
Do you have a suspected or confirmed mould infection?
Are you able to receive medication through a drip into your vein?
Are you willing to discuss and sign an informed consent form?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would be randomly assigned to receive either the new medicine, EL219, or one of the standard treatments (liposomal amphotericin B or voriconazole). The study is 'double-blind', meaning neither you nor your study doctor will know which treatment you are receiving. All treatments will be given through a drip into your vein.

Throughout the study, you will have regular visits to the clinic for medical examinations, blood tests, and possibly other scans to check how you are responding to the treatment and to monitor for any side effects. These assessments are important to ensure your safety and to understand how well the medicine is working. You will need to make sure you have reliable access to a vein for the intravenous medication. The full duration of your participation, including follow-up appointments, will be clearly explained by the study team.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. Potential benefits could include receiving cutting-edge treatment that might be more effective than standard options, and close monitoring of your health by a dedicated medical team. You would also be contributing valuable information that could help others with severe mould infections in the future. However, there are potential risks, including side effects from the study medication, which could be similar to or different from those of existing treatments. There's also no guarantee that the new medicine will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

U. of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
UC Davis Medical Center
Verified postcode
Sacramento, United States· Recruiting
U. of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Washington U.
Verified postcode
St Louis, United States· Recruiting
U. of Texas, MD Anderson
Verified postcode
Houston, United States· Recruiting
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet
Verified postcode
Brussels, Belgium· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Juravinski Hospital
Verified postcode
Hamilton, Canada· Recruiting
AP-HP Hopital Henri Modor
Verified postcode
Créteil, France· Recruiting
Hospital del Mar
Verified postcode
Barcelona, Spain· Recruiting
Hospital Clinic Barcelona
Verified postcode
Barcelona, Spain· Recruiting

Common questions

What is an invasive mould infection?

It's a serious fungal infection caused by moulds that can affect people with weakened immune systems, potentially spreading throughout the body.

What does 'Phase 2' mean for a study?

Phase 2 is an early stage where a new medicine is tested on a small group of people to see if it's safe and shows promise for treating a condition, before larger studies begin.

Will I know if I'm getting the new medicine or an old one?

No, because this is a 'double-blind' study, neither you nor your study doctor will know which treatment you are receiving until the study is over. This helps ensure fair results.

How will I receive the treatment?

The study medicine or comparator will be given to you through a drip directly into your vein (intravenously).

Can I leave the study if I change my mind?

Yes, absolutely. You can decide to leave the study at any point, and it will not affect your ongoing medical care or your relationship with your doctors.

How to find out more

Laura A. Navalta

info@eliontx.com 443-423-1785 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.