Business Wire·Jul 7, 2026, 8:05 AM ET

Turn Therapeutics Announces Final Stage 2 Design and Data-Driven Expansion of GX-03 Phase 2 Program in Atopic Dermatitis

TTRX

Turn Therapeutics completed a comprehensive interim analysis of its adaptive Phase 2 trial for GX-03, identifying clinically meaningful efficacy across a broader spectrum of atopic dermatitis severity than anticipated.
The final Stage 2 design expands the ongoing program to evaluate patients across the full range of baseline disease severity defined by the Eczema Area and Severity Index (EASI), including the mild-to-moderate range (EASI 1.1 to 7.0).
The study will enroll approximately 120 to 135 patients stratified into three baseline EASI groups (1.1-7.0, 7.1-15.9, & ≥16) with 1:1 randomization maintained within each stratum.
Final Stage 2 design employs the FDA-recognized Hochberg multiple testing procedure to establish statistical significance across four prespecified efficacy endpoints: Week 4 vIGA-AD Success, Week 4 EASI-75, Week 8 EASI-90, & Week 8 EASI-100.
Baseline pruritus severity was identified as a potential biomarker of treatment response to support prospective population enrichment.
Week 4 data demonstrated the earliest treatment separation between GX-03 and vehicle, highlighting the potential for a rapidly acting topical therapy.
GX-03 showed favorable safety & tolerability with no treatment-related serious adverse events, discontinuations, or tolerability issues reported to date.
Enrollment continues uninterrupted with all previously enrolled patients remaining blinded & incorporated into the final Stage 2 efficacy population.
Turn Therapeutics anticipates completing enrollment during the fourth quarter of 2026.
The company confirmed sufficient capitalization to support study completion & planned operations through the third quarter of 2027.
An investor webcast was hosted on July 7 at 4:30 p.m. Eastern Time to discuss the interim analysis & optimized Stage 2 design.