Clinically meaningful efficacy observed across a broader spectrum of atopic dermatitis supports expansion of the ongoing Phase 2 program to prospectively evaluate patients across the full range of disease severity as defined by the Eczema Area and Severity Index (EASI)

Comprehensive interim review identifies optimal patient population, endpoint strategy, disease stratification, and statistical methodology for final Stage 2 design of the Company's ongoing adaptive Phase 2 trial in atopic dermatitis

Final Stage 2 design will employ the FDA-recognized Hochberg multiple testing procedure, allowing statistical significance to be established across multiple efficacy endpoints rather than a single primary endpoint

Company to host investor webcast today at 4:30 p.m. Eastern Time

Turn Therapeutics, Inc. (NASDAQ:TTRX), a clinical-stage biotechnology company developing targeted, non-systemic therapies for inflammatory skin diseases, today announced the completion of a comprehensive interim analysis of its ongoing adaptive Phase 2 clinical trial evaluating GX-03 for the treatment of atopic dermatitis.

The multi-week review resulted in the final Stage 2 study design, incorporating data-driven refinements to patient selection, disease stratification, endpoint evaluation, and statistical methodology. Importantly, the review identified clinically meaningful efficacy across a broader spectrum of atopic dermatitis severity than originally anticipated, enabling expansion of the ongoing Phase 2 program to prospectively evaluate patients across the full spectrum of baseline disease severity as measured by the Eczema Area and Severity Index (EASI).

Following the Company's previously disclosed preliminary interim review of the first 50 completed subjects and under the oversight of the Independent Data Monitoring Committee, Turn Therapeutics initiated a comprehensive planned interim analysis led by Bruce Stouch, Ph.D., the study's lead biostatistician, together with Dr. Stephen Hahn, Executive Clinical and Regulatory Lead for Turn Therapeutics and former Commissioner of the U.S. Food and Drug Administration. The multi-week review comprehensively evaluated treatment-response patterns, baseline disease characteristics, efficacy across prespecified and exploratory endpoints, and clinically relevant patient characteristics to maximize the scientific value of the Stage 1 dataset and optimize the final Stage 2 study design, which is intended to serve as the primary efficacy phase supporting future regulatory development. Enrollment continued uninterrupted throughout the review under the adaptive trial design, and all patients enrolled during this period remain blinded and will be prospectively evaluated under the final Stage 2 study design.

The comprehensive interim review confirmed preliminary observations that Week 4 provided the earliest and clearest treatment separation between GX-03 and vehicle, supporting inclusion of Week 4 efficacy endpoints in the final Stage 2 design and highlighting the potential for a rapidly acting topical therapy across the atopic dermatitis severity spectrum. The analyses also identified baseline pruritus severity as a potential biomarker of treatment response, supporting prospective enrichment of the Stage 2 population. In addition, GX-03 demonstrated clinically meaningful efficacy in patients with baseline Eczema Area and Severity Index (EASI) scores of 1.1 to 7.0, a population generally considered to have mild-to-moderate disease according to the EASI scale, expanding the range of disease severity prospectively evaluated in Stage 2 beyond what was originally anticipated. Collectively, these findings supported a final Stage 2 design evaluating one unified patient population across the full baseline EASI spectrum using multiple efficacy endpoints.