LOS ANGELES– Turn Therapeutics has initiated a clinical trial to evaluate GX-03, a first-in-class topical formulation targeting interleukin (IL)-36 and IL-31 for the treatment of moderate-to-severe eczema (atopic dermatitis). Patient dosing began on July 11 in Dallas, marking a significant milestone in the company’s development of new, non-invasive therapies for chronic skin conditions.
The randomized, double-blind, vehicle-controlled study aims to enroll 114 participants and will span an eight-week treatment period. The trial’s primary endpoint is improvement in patients’ Eczema Area and Severity Index (EASI) scores, with secondary endpoints including Investigators Global Assessment (IGA) and Max-Itch assessment scores. Top-line results are expected by the end of 2025.
“Patients with moderate-to-severe eczema often face limited treatment options, from painful or costly injectables to steroids that can cause long-term side effects,” said Bradley Burnam, CEO of Turn Therapeutics. “Dosing our first patients in this clinical trial is a milestone in our mission to deliver an easy-to-use, safe, topical therapy that improves patients’ quality of life.”
GX-03 is based on the same formulation used in Turn’s wound care product Hexagen, which is already cleared by the U.S. Food and Drug Administration for both acute and chronic wound care. Preclinical research has demonstrated the formulation’s potent inhibition of inflammatory cytokines, including IL-36 alpha and gamma—linked to eczema and psoriasis—and IL-31, a key driver of itching in eczema. The compound has also shown activity against IL-4, associated with broader inflammatory responses.
The trial represents the first clinical use of a topical IL-36 inhibitor, a novel approach that could potentially eliminate the need for injectable biologics or long-term steroid use in treating eczema.
“For years, patients like me have been offered outdated, one-size-fits-all treatments that fail to address the root causes of disease,” Burnam added. “This trial is designed to deliver proof of concept toward our goal of successfully and safely treating the source of eczema, rather than simply managing its symptoms.”
Turn Therapeutics is also exploring expanded indications for GX-03, including onychomycosis (toenail fungus), as it seeks to develop broader applications for its immunomodulatory formula.
