Turn Therapeutics Launches Trial for AD Topical GX-03

Image Credit: © DermNet

Today, Turn Therapeutics announced the commencement of a randomized, double-blind, vehicle-controlled clinical trial evaluating its topical GX-03 formation for the treatment of moderate to severe atopic dermatitis (AD).¹ The study, which began patient dosing on July 11 in Dallas, represents the first clinical trial of a topical IL-36 inhibitor. This trial builds upon promising preclinical findings that demonstrated GX-03’s immunological activity in modulating key inflammatory cytokines associated with eczema.²

"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, in a news release. "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, the active formulation previously integrated into Turn’s FDA-cleared wound care product Hexagen, is now under formal investigation as a potential drug treatment. While Hexagen has already achieved clearance for use in acute and chronic wound care, the current trial marks a new direction for Turn Therapeutics as it seeks to expand GX-03’s use into the dermatologic drug space. The company noted it is also pursuing indications for onychomycosis.

Study Methods

The phase 1/2 clinical study aims to enroll 114 patients with moderate to severe AD. The study will span an 8-week treatment duration, during which the primary endpoint will be the change in Eczema Area and Severity Index (EASI) scores from baseline. Secondary endpoints include the Investigator Global Assessment (IGA) and Max-Itch assessments, offering a comprehensive picture of the product’s therapeutic effects on both visible skin symptoms and pruritus-related discomfort.

Mechanism of Action and Background

The mechanism behind GX-03 lies in its ability to inhibit IL-36 alpha and IL-36 gamma—cytokines increasingly recognized for their role in the pathophysiology of inflammatory skin disorders, including eczema and psoriasis. In addition, GX-03 has shown suppressive effects on IL-4 and IL-31, both of which are involved in inflammatory and itch pathways, respectively. The company noted IL-31, in particular, hasemerged as a key target in addressing eczema-related itch, a hallmark symptom that significantly impairs patients' quality of life.

With more than 200,000 human uses and a favorable safety profile established through prior wound care applications, GX-03 is entering this trial with a well-documented background in real-world use. The transition from medical device to drug development highlights a broader industry trend of repurposing known, safe technologies to address unmet clinical needs in dermatology.

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

Conclusion

Top-line results from the study are expected by the end of 2025. If successful, GX-03 could emerge as a novel, non-steroidal therapeutic option for patients who require safe, effective alternatives to current systemic or corticosteroid-based therapies.

References

1. Turn Therapeutics begins clinical trial of first topical IL-36/IL-31 inhibitor for eczema. News Release. Business Wire. Published July 14, 2025. Accessed July 14, 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. BioSpace. June 20, 2024. Accessed July 14, 2025. https://www.biospace.com/article/releases/turn-therapeutics-atopic-dermatitis-candidate-reduces-disease-severity-by-57-percent-in-vivo/#:~:text=All%20(816%2C573)-,Turn%20Therapeutics%20Atopic%20Dermatitis%20Candidate,Severity%20by%2057%25%20In%2DVivo&text=LOS%20ANGELES%2D%2D(BUSINESS%20WIRE,in%20disease%20severity%20versus%20placebo