Turn Therapeutics Launches First Clinical Trial to Assess Topical IL-36 Inhibitor for Atopic Dermatitis

Turn Therapeutics has launched a randomized, double-blind, vehicle-controlled phase 1/2 clinical trial to evaluate GX-03, a topical formulation targeting interleukin (IL)-36 and IL-31, for the treatment of moderate-to-severe atopic dermatitis (AD).1

The study, which began participant dosing on July 11 in Dallas, TX will enroll 114 adults who will follow an 8-week course of treatment. The primary efficacy endpoint is change in Eczema Area and Severity Index (EASI) scores from baseline. Secondary endpoints include Investigators Global Assessment (IGA) and Max-Itch assessment scores. According to a July 14 statement from Turn Therapeutics, top-line results are expected by the end of 2025.1

“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,” Bradley Burnam, CEO of Turn Therapeutics, said in the statement. “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.”1

GX-03, the active compound in Turn’s previously FDA-cleared wound care product Hexagen, represents the first investigational topical agent to target IL-36 in AD. IL-36 is implicated in the inflammatory cascade that drives atopic dermatitis. The formulation has also demonstrated inhibition of IL-31, a cytokine associated with pruritus. According to Turn Therapeutics, earlier in vivo studies confirmed GX-03’s ability to inhibit IL-36 alpha and IL-31, as well as IL-4 and IL-36 gamma, which are linked to eczema and psoriasis, respectively.

The current study follows and augments findings from a preclinical trial that demonstrated GX-03’s immunological activity in modulating key pro-inflammatory cytokines associated with eczema.2

Burnam added, "For years, patients like me have been offered outdated, one-size-fits-all treatments that fail to address the root causes of disease. 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.”1

GX-03 has an established safety profile from more than 200,000 uses in wound care, according to Turn Therapeutics. The company is pursuing drug approval for GX-03 as a treatment for both atopic dermatitis and onychomycosis.1

References

1. Turn Therapeutics begins clinical trial of first topical IL-36/IL-31 inhibitor for eczema. News release. Turn Therapeutics. July 14, 2025. Accessed July 15, 2025. http://businesswire.com/news/home/20250714700228/en/Turn-Therapeutics-Begins-Clinical-Trial-of-First-Topical-IL-36IL-31-Inhibitor-for-Eczema

2. Turn Therapeutics atopic dermatitis candidate reduces disease severity by 57% in-vivo. News release. Turn Therapeutics. June 20, 2024. Accessed July 15, 2025. https://www.biospace.com/turn-therapeutics-atopic-dermatitis-candidate-reduces-disease-severity-by-57-percent-in-vivo