Turn Therapeutics Expands GX-03 Phase 2 Trial to 135 Patients after 71% Week 4 Efficacy
TTRX•Turn Therapeutics expanded its GX-03 Phase 2 trial to enroll patients across the full baseline EASI 1.1–≥16 spectrum after interim data showed 71.4% Week 4 vIGA-AD success versus 33.3% for vehicle in the 1.1–7.0 subgroup. Final Stage 2 will enroll 120–135 patients using Hochberg testing and Week 4/8 endpoints.
1. Interim Analysis Results
A comprehensive interim review of the first 50+ subjects identified clinically meaningful efficacy in the EASI 1.1–7.0 subgroup (n=14), with Week 4 vIGA-AD success of 71.4% versus 33.3% (n=18), Week 4 EASI-100 at 28.6% versus 5.6% (+23.0%), and Week 8 EASI-100 at 35.7% versus 11.1% (+24.6%).
2. Final Stage 2 Design
The optimized design will enroll approximately 120–135 patients across the full EASI spectrum (1.1–7.0, 7.1–15.9, ≥16), employ the FDA-recognized Hochberg multiple testing procedure for multiple efficacy endpoints, and include both Week 4 and Week 8 assessments under a unified patient population.
3. Development and Labeling Implications
Week 4 emerged as the earliest point of clear treatment separation, and baseline pruritus severity was identified as a potential biomarker, supporting rapid-acting topical positioning and broader development into mild-to-moderate and severe atopic dermatitis labeling opportunities.
