Turn Therapeutics Inc said Tuesday that it has broadened the patient population in its GX-03 atopic dermatitis program after a comprehensive interim analysis of the ongoing adaptive Phase 2 trial found efficacy across a wider range of disease severity than initially anticipated.
The clinical-stage biotechnology firm said the interim review identified clinically meaningful responses when patients were analyzed across the full baseline Eczema Area and Severity Index - EASI - spectrum. Based on those findings, the company will prospectively evaluate patients across the entire baseline EASI range in the final Stage 2 protocol.
Under the finalized Stage 2 design, Turn Therapeutics plans to enroll approximately 120-135 patients, who will be stratified into three baseline EASI severity groups. The study will assess four prespecified efficacy endpoints and will apply the FDA-recognized Hochberg multiple testing procedure to control for multiplicity.
The interim analysis specifically highlighted a subgroup of patients with baseline EASI scores between 1.1 and 7.0, a group generally considered to represent mild-to-moderate disease. In that subgroup, 71.4% of patients treated with GX-03 achieved Week 4 vIGA-AD Success, compared with 33.3% of patients receiving vehicle, a difference of 38.1 percentage points.
Turn Therapeutics said Week 4 provided the earliest and clearest separation between GX-03 and vehicle, and that observation supported the decision to include Week 4 efficacy endpoints in the Stage 2 design.
On safety, the company reported no treatment-related serious adverse events in either treatment arm, and no treatment-related tolerability issues or study discontinuations were identified in the interim review. Enrollment continued without interruption during the analysis.
Market reaction was immediate - shares of Turn Therapeutics (NASDAQ: TTRX) rose 3.8% in premarket trading on Tuesday following the announcement.
The Westlake Village, California-based company said it remains funded to support completion of the study and planned operations through the third quarter of 2027. Turn Therapeutics expects to complete enrollment for the Stage 2 study during the fourth quarter of 2026.
Taken together, the company said the interim results and subsequent protocol adjustments will allow the trial to evaluate GX-03 across a broader patient population while preserving predefined statistical rigor through prespecified endpoints and the Hochberg multiple testing procedure.
Study details at a glance
- Interim analysis found clinically meaningful efficacy across a wider spectrum of baseline EASI scores.
- Final Stage 2 will enroll approximately 120-135 patients stratified into three baseline EASI severity groups.
- Four prespecified efficacy endpoints will be evaluated using the Hochberg procedure.