Turn Therapeutics announced an optimized, expanded Stage 2 design for its GX-03 Phase 2 atopic dermatitis trial after a comprehensive interim analysis showing meaningful efficacy across the full EASI severity spectrum.
Key Highlights:
- Comprehensive interim review led to a final Stage 2 design and expansion to enroll patients across full baseline EASI spectrum (EASI ≥1.1).
- Final Stage 2 will include ~120–135 patients, stratified into EASI 1.1–7.0, 7.1–15.9 and ≥16 with 1:1 randomization within strata.
- Study will evaluate four prespecified endpoints (Week 4 vIGA-AD success, Week 4 EASI-75, Week 8 EASI-90, Week 8 EASI-100) using the Hochberg multiple testing procedure.
- Interim data: GX-03 showed notable treatment differences vs vehicle (e.g., Week 4 vIGA-AD success 71.4% vs 33.3% in EASI 1.1–7.0 subgroup; Δ +38.1%).
- No treatment-related serious adverse events observed; enrollment uninterrupted and expected to complete in Q4 2026 with capitalization through Q3 2027.
Original SEC Filing:
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