RecruitingPhase 2NCT07215273

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

A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 (Turletricin) Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy of Invasive Mould Infections (TREAT-1)


Sponsor

Elion Therapeutics, Inc.

Enrollment

60 participants

Start Date

Feb 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if EL219 is safe and effective compared to liposomal amphotericin B (LAmB) or voricanozole for early treatment of invasive mould infections


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Active Comparator- IV Antifungal (LAmB or voriconazole) and a drug called EL219 for people with invasive mould infection. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEL219

EL219 is specifically being developed for early antifungal therapy (EAT), when infection is suspected due to highly suggestive signs and symptoms of disease; in high-risk people, antifungals are recommended even before confirmation of the microbial cause of infection, because delayed therapy is associated with poor outcomes in those who lack adequate immune responses. EL219 may provide a once-weekly alternative to LAmB and other polyenes that could also reduce the toxicities that often limit the frequency and duration of administration for these highly efficacious antifungals.

DRUGActive Comparator- IV Antifungal (LAmB or voriconazole)

LAmB has broad-spectrum activity but its use is limited by toxicity and once-daily IV administration. It is not administered outside of the monitored setting given risks for electrolyte disturbances and cardiac arrhythmias. Voriconazole is a first-line therapy for IA and the most common azole used in the US and globally but does not have activity against many non-Aspergillus moulds.


Locations(23)

U. of Alabama at Birmingham

Birmingham, Alabama, United States

UC Davis Medical Center

Sacramento, California, United States

Augusta University Medical Center

Augusta, Georgia, United States

John Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

U. of Michigan

Ann Arbor, Michigan, United States

Washington U.

St Louis, Missouri, United States

U. of Texas, MD Anderson

Houston, Texas, United States

U. of Washington

Seattle, Washington, United States

AZ Sint-Jan Brugge

Bruges, Belgium

Universite Libre de Bruxelles (ULB) - Institut Jules Bordet

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Juravinski Hospital

Hamilton, Ontario, Canada

University Health Network (UHN) - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier d'Argenteuil

Argenteuil, France

AP-HP Hopital Henri Modor

Créteil, France

Istituto Europeo di Oncologia

Milan, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS- Universita Cattolica del Sacro Cuore

Roma, Italy

Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

View Full Details on ClinicalTrials.gov

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NCT07215273