Turn Therapeutics, Inc. (NASDAQ:TTRX) on Tuesday said a planned interim analysis of its adaptive Phase 2 trial of GX-03 for atopic dermatitis has led to refinements in the study design and an expansion of the patient population.
The company said the multi-week review finalized the Stage 2 protocol by refining patient selection, disease stratification, efficacy endpoints, and statistical methodology.
Based on the findings, the ongoing study will now prospectively evaluate patients across the full spectrum of baseline disease severity measured by the Eczema Area and Severity Index, or EASI.
Interim Analysis Shapes Final Study Design
The interim review followed the company’s previously disclosed analysis of the first 50 completed patients and was conducted under the oversight of the Independent Data Monitoring Committee.
According to the company, enrollment continued without interruption during the review, with all newly enrolled patients remaining blinded and included in the final Stage 2 analysis.
The analysis confirmed that Week 4 produced the earliest and clearest separation between GX-03 and the vehicle control, supporting the addition of Week 4 efficacy endpoints to the final study design. The company also identified baseline pruritus severity as a potential biomarker for treatment response.
Broader Patient Population Added To Phase 2 Trial
Turn Therapeutics said one of the key findings was treatment activity among patients with baseline EASI scores ranging from 1.1 to 7.0, a group generally classified as having mild-to-moderate atopic dermatitis.
Within this subgroup, GX-03 demonstrated improvements in Week 4 vIGA-AD Success and complete disease clearance at both Week 4 and Week 8 compared with the vehicle treatment.
Based on these findings, the final Stage 2 design will continue evaluating patients with greater inflammatory burden while expanding enrollment to include patients across the full baseline EASI spectrum.
The revised Stage 2 trial will enroll approximately 120 to 135 patients.
The company said no treatment-related serious adverse events, tolerability issues, or study discontinuations have been reported in either treatment group.
Turn Therapeutics expects to complete enrollment in the fourth quarter of 2026 and said it has sufficient capital to support the study and planned operations through the third quarter of 2027.
TTRX Price Action: Turn Therapeutics shares were up 13.13% at $8.69 at the time of publication on Tuesday, according to Benzinga Pro data.
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