Turn Therapeutics has finalized the Stage 2 design of its Phase 2 GX-03 trial for atopic dermatitis, guided by encouraging interim data. The updated study expands eligibility to include a broader range of eczema severity to further evaluate the treatment in a wider patient population.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
Turn Therapeutics has announced interim findings from its ongoing adaptive Phase 2 trial of GX-03 in atopic dermatitis while finalizing the study’s Stage 2 design based on the planned interim analysis. The updated protocol broadens patient eligibility, refines efficacy endpoints and statistical methods, and will guide the remainder of the Phase 2 study.
Disease Background
Atopic dermatitis (eczema) is a chronic inflammatory skin disease characterized by persistent itching, dry skin, redness, and recurrent rashes. It affects approximately 15–20% of children and 2–10% of adults worldwide.
Current treatment options include moisturizers, topical corticosteroids, calcineurin inhibitors, phosphodiesterase-4 inhibitors, and, for moderate-to-severe disease, biologics and Janus kinase (JAK) inhibitors. Despite these therapies, many patients continue to experience inadequate symptom control, recurrent disease flares, treatment-related adverse effects, or require long-term treatment, highlighting the need for additional therapeutic options.
GX-03 is Turn Therapeutics’ lead investigational non-systemic topical therapy for moderate-to-severe atopic dermatitis. Applied directly to the skin, it is intended to deliver anti-inflammatory activity at the site of disease while minimizing systemic exposure.
Mechanism of Action
According to the company, GX-03 targets inflammatory cytokines involved in the development of atopic dermatitis, including IL-36α and IL-36γ. It also reduces signaling associated with IL-4 and IL-31, with the goal of controlling inflammation, relieving itch, and supporting restoration of the skin barrier while limiting systemic exposure.
Interim Clinical Evidence
GX-03 is currently being evaluated in an ongoing adaptive Phase 2 clinical trial (NCT07355075). Interim findings showed clinically meaningful improvements across multiple efficacy endpoints in patients treated with GX-03.
By Week 4, 61.5% of patients receiving GX-03 achieved vIGA-AD Success, compared with 8.3% in the vehicle group, while 69.2% achieved EASI-75, versus 25.0% with vehicle treatment. Clinical benefits continued through Week 8, with 53.8% of GX-03-treated patients achieving EASI-90 and 46.2% achieving EASI-100, indicating near-complete or complete skin clearance.
The interim analysis also demonstrated clinically meaningful responses in patients with mild-to-moderate atopic dermatitis (baseline EASI score 1.1–7.0), supporting the company’s decision to expand the ongoing Phase 2 trial to prospectively include patients across a broader spectrum of disease severity.
Safety Findings
GX-03 remained well tolerated during the interim analysis. Investigators reported no treatment-related serious adverse events, treatment-related study discontinuations, or clinically significant tolerability concerns, supporting continued evaluation in the Phase 2 study.
Expert Perspective and Path Forward
Turn Therapeutics Chief Executive Officer Bradley Burnam said the interim analysis enabled the company to optimize the Stage 2 trial design while supporting expansion of the study to include patients across a broader range of disease severity.
The review was conducted with Dr. Stephen M. Hahn, former U.S. FDA Commissioner and Turn Therapeutics’ Executive Clinical and Regulatory Lead, to refine patient selection, endpoint strategy, disease stratification, and statistical methodology for future regulatory development.
The finalized Stage 2 study will prospectively enroll approximately 120 to 135 patients across three baseline EASI severity groups (1.1–7.0, 7.1–15.9, and ≥16) with 1:1 randomization within each stratum. The trial will evaluate four prespecified efficacy endpoints: Week 4 vIGA-AD Success, Week 4 EASI-75, Week 8 EASI-90, and Week 8 EASI-100. Statistical analyses will use the FDA-recognized Hochberg multiple testing procedure, enabling assessment of multiple clinically meaningful efficacy endpoints while controlling the overall Type I error rate.
Turn Therapeutics expects to complete patient enrollment during the fourth quarter of 2026, with the resulting data intended to support future regulatory submissions if the trial is successful.
What It Means for Patients
If future clinical studies confirm these findings, GX-03 may provide patients with atopic dermatitis a topical treatment capable of delivering meaningful symptom relief without systemic immune suppression or injectable therapy. However, GX-03 remains an investigational therapy and has not been approved for clinical use.
References
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.