Turn Therapeutics (TTRX) Study update summary

Study design and methodology

• GX-03 Phase II trial for atopic dermatitis uses a staged adaptive, double-blind, vehicle-controlled design, refining Stage 2 based on interim data from the first 50 patients to optimize for higher success probability and resource efficiency.

• Enrollment continued uninterrupted during interim analysis, with all patients remaining blinded and included in the final Stage 2 analysis, maintaining trial integrity and efficiency.

• Stage 2 will enroll approximately 120–135 patients aged 18–80, stratified into three EASI severity groups and by pruritus severity, with balanced 1:1 randomization between drug and vehicle arms.

• The Hochberg procedure is used for multiplicity control across four prespecified efficacy endpoints at weeks 4 and 8.

• The final Stage 2 design aims to maximize scientific value, regulatory support, and statistical power for future development.

Interim results and efficacy findings

• In the EASI 1.1–7 subgroup, GX-03 showed a 71.4% vIGA-AD/IGA success rate versus 33.3% for vehicle, with significant treatment differences at week 4 and week 8 EASI-100 (35.7% vs 11.1%).

• Moderate-severe AD subgroup (IGA 3/4, EASI≥10) showed GX-03 outperforming vehicle in week 4 vIGA-AD success (55.6% vs 25%) and EASI-75 (88.9% vs 50%).

• In the EASI≥1.1 and PP-NRS≥7 subgroup, GX-03 outperformed vehicle across all endpoints, e.g., week 4 vIGA-AD success 61.5% vs 8.3%, EASI-75 69.2% vs 25%, and week 8 EASI-100 46.2% vs 8.3%.

• Higher baseline pruritus severity correlated with stronger GX-03 responses, supporting enrichment strategies for Stage 2.

• Retrospective application of the optimized Stage 2 design to the first 50 completers confirmed robust efficacy, with notable separation at all four primary endpoints.

Safety and regulatory update

• No treatment-related serious adverse events, new safety signals, or tolerability issues were observed in either treatment group; one mild warming sensation and one unrelated common cold reported.

• The trial is overseen by an independent Data and Safety Monitoring Committee, supporting confidence in tolerability.

• Sufficient capital is available to support study completion and operations through Q3 2027.

• Continued enrollment is expected to accelerate completion, with a Phase II data readout targeted for Q4 2026.

• A Type B FDA meeting is planned to discuss Phase III design, aiming for Phase III initiation in mid-2027, pending successful Phase II results and regulatory alignment.