Turn Therapeutics Begins Clinical Trial of First Topical IL-36/IL-31 Inhibitor for Eczema

LOS ANGELES--(BUSINESS WIRE)--Turn Therapeutics today announced the initiation of a randomized, double-blind, vehicle-controlled clinical trial evaluating its topical GX-03 formulation -- previously used in the company's advanced wound care product Hexagen -- for the treatment of moderate-to-severe eczema (atopic dermatitis). Patient dosing commenced on July 11 in Dallas.

Designed to support new drug approval, this clinical trial builds on in-vivo confirmation of the formulation's potent immunological inhibition of key eczema-related cytokines, including interleukin (IL)-36. It also marks the first clinical trial of a topical IL-36 inhibitor.

"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."

Turn Therapeutics is targeting enrollment of 114 patients with moderate-to-severe eczema in the trial, which will include an eight-week treatment course. The study's primary efficacy endpoint is the change in patients' Eczema Area and Severity Index (EASI) scores from baseline, with secondary endpoints that include Investigators Global Assessment (IGA) and Max-Itch assessment scores. Top-line results are expected by end of 2025.

Earlier studies have demonstrated Hexagen's ability to inhibit IL-36 alpha, a cytokine with inflammatory effects recognized as a primary driver of eczema; IL-36 gamma, a cytokine associated with psoriasis; and IL-4, another cytokine linked to inflammation. Notably, the formula also has shown significant inhibitory activity against IL-31, the cytokine associated with itching, indicating potential for improving patients' comfort and quality of life.

The formula has previously been cleared by the U.S. FDA for acute and chronic wound care indications. Turn is pursuing expanded indications for the formula, including as a drug treatment for both moderate-to-severe eczema and onychomycosis (toenail fungus).

"For years, patients like me have been offered outdated, one-size-fits-all treatments that fail to address the root causes of disease," Burnam said.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

For more information or to request an interview with Turn Therapeutics CEO Bradley Burnam, please contact Ellie Pickel at [phone] or [e-mail].

About Turn Therapeutics

Turn Therapeutics is a pharmaceutical and medical device organization specializing in the development of advanced wound and dermatology solutions. Utilizing its proprietary technology and patient-first approach, Turn Therapeutics addresses critical needs in healthcare, aiming to improve access, outcomes, and quality of life. Visit turntherapeutics.com to learn more about the company.

About Hexagen/GX-03

Turn Therapeutics' flagship formula has achieved three FDA clearances in advanced wound and skin care. It has an extensive safety history with over 200,000 human uses. The active ingredient in GX-03 has well characterized antimicrobial and anti-inflammatory characteristics. Turn Therapeutics' eczema and onychomycosis programs represent its first formal development for use as a U.S. drug active ingredient.

Forward-Looking Statements

This press release may contain forward-looking statements, including statements regarding the future development, regulatory approval, and potential clinical or commercial success of GX-03. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual outcomes to differ materially. Factors that may affect future results include, but are not limited to, the success and timing of clinical trials, regulatory interactions, and the ability to demonstrate safety and efficacy in target indications. Turn Therapeutics undertakes no obligation to update any forward-looking statements, except as required by applicable law.