Elion Therapeutics Initiates Phase 2 Trial for Turletricin in Invasive Mould Infection

Novel antifungal drug granted QIDP and Fast Track designations by FDA

Apr. 16, 2026 at 6:04am

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A translucent, ghostly X-ray image revealing the detailed internal structure of a fungal spore, conveying the scientific and clinical focus of the story about a new antifungal drug in development.An X-ray view of a fungal spore structure highlights the complex internal mechanisms that new antifungal therapies aim to target.Deerfield Today

Elion Therapeutics, a biotechnology company focused on transforming the treatment of life-threatening fungal infections, has announced the initiation of a Phase 2 clinical trial evaluating its investigational drug turletricin (EL219) for early antifungal therapy in participants with suspected and confirmed invasive mould infection (IMI). Turletricin has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, intended to support the development of new therapies for serious or life-threatening infections.

Why it matters

Invasive mould infections can cause severe or life-threatening illness in people with weakened immune systems, and early treatment is critical for improved patient outcomes. The initiation of this Phase 2 trial represents a key milestone for turletricin, which is designed as a once-weekly, broad-spectrum, non-nephrotoxic polyene antifungal that could offer advantages over the current standard of care.

The details

The Phase 2 global TREAT-1 clinical trial is a multicenter, randomized, double-blind study evaluating the safety and efficacy of turletricin versus standard of care for early antifungal therapy in participants with suspected and confirmed IMI. The primary outcome measure is all-cause mortality at Day 21 in the Intent-to-Treat (ITT) analysis set.

  • The Phase 2 TREAT-1 clinical trial has been initiated.
  • Elion will present data on turletricin at the 2026 ESCMID Global Congress on April 18th.

The players

Elion Therapeutics

A biotechnology company dedicated to transforming the treatment of life-threatening fungal infections.

Turletricin (EL219)

A next-generation amphotericin B derivative that is engineered to be less toxic to the kidneys while retaining broad-spectrum antifungal activity.

Dr. Kieren Marr

CEO of Elion Therapeutics.

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What they’re saying

“The QIDP designation and initiation of the TREAT-1 study, with its novel design, represents a key milestone for turletricin and underscores its distinctive potential as a once-weekly, broad-spectrum, non-nephrotoxic polyene antifungal used early in people with suspected IMI.”

— Dr. Kieren Marr, CEO of Elion Therapeutics

What’s next

The Phase 2 TREAT-1 clinical trial is ongoing, and Elion plans to present additional data on turletricin at the 2026 ESCMID Global Congress.

The takeaway

Turletricin, a novel antifungal drug designed to be less toxic to the kidneys, represents a promising new approach to treating invasive mould infections, which can be life-threatening for people with weakened immune systems. The initiation of this Phase 2 trial is an important step in the development of this potential new therapy.