Turn Therapeutics Refines GX-03 Eczema Trial After Interim Data, Eyes 2026 Readout

Key Points

• Turn Therapeutics refined the stage two design of its GX-03 phase II eczema trial after an interim analysis of the first 50 completers, using a staged adaptive approach without pausing enrollment.
• The interim data suggested stronger responses in patients with lower EASI scores and higher baseline itch, leading the company to enrich stage two by requiring a PP-NRS itch score of at least 7 and stratifying patients by EASI severity.
• Turn said GX-03 has shown a favorable safety profile so far, with no treatment-related serious adverse events, and expects a stage two readout in Q4 2026 before discussing phase III plans with the FDA.

Turn Therapeutics NASDAQ: TTRX outlined the final stage two design and data-driven expansion of its GX-03 phase II program in atopic dermatitis during an investor update call, saying the revised approach was informed by an interim analysis of the first 50 completers in the ongoing trial.

Brad Burnam, founder and chief executive officer of Turn Therapeutics, said the company used a staged adaptive study design to refine the second stage without pausing enrollment. He described the approach as a way to use data from the company’s own trial population to improve the next stage while maintaining trial integrity under the oversight of a Data Monitoring Committee.

“The trial remains ongoing. Enrollment did not pause throughout this interim review period,” Burnam said. He added that the company believes the staged design offers “a higher probability of success” because it uses the same population, investigators and patient population as the initial stage.

Interim Analysis Expands Focus Beyond Initial EASI Threshold

Burnam spent part of the presentation explaining the distinction between two common measures used in eczema trials: the Validated Investigator Global Assessment for Atopic Dermatitis, or vIGA-AD, and the Eczema Area and Severity Index, or EASI. He said vIGA-AD measures the worst lesion on the body on a zero-to-four scale, while EASI also accounts for the amount of body surface area affected.

According to Burnam, Turn had initially identified an EASI score of at least 10 as a likely marker for a moderate-to-severe population in stage two. However, the company’s interim analysis showed potentially meaningful results in patients with EASI scores from 1.1 to 7, a group he described as having lower total affected surface area but still clinically meaningful disease based on lesion severity and symptoms.

In that subgroup of roughly 32 patients, Burnam said the drug arm showed a 71.4% response on IGA success compared with 33.3% for vehicle, representing a 38.1% treatment difference. He said the p-value was less than 0.05 for that population, though the value was not displayed in the company’s slide. The company also reported separations for EASI-100, which Burnam described as total clearance of the body’s EASI burden, of 23.1% at week four and 24.6% at week eight.

Itch Score Used to Enrich Stage Two Population

Burnam said the company also evaluated predictive variables that could influence trial success and identified baseline pruritus, or itch, as an important factor. The company uses the Peak Pruritus Numerical Rating Scale, or PP-NRS, which runs up to 10 points.

He said the company saw greater separation across endpoints as baseline itch scores increased from five to six to seven. As a result, Turn plans to enrich the stage two population by requiring a PP-NRS score of at least seven.

Applying the revised stage two design retrospectively to the first 50 completers produced a group of 25 patients, Burnam said. In that population, the company reported a 53.2% treatment difference for week four IGA success and said the p-value was below 0.05. Burnam also said week four EASI-75 had a p-value below 0.05, with 69.2% of patients on drug achieving the endpoint versus 25% on vehicle. The company also reported treatment differences of 37.1% for week eight EASI-90 and 37.9% for week eight EASI-100.

Stage Two Design Includes Stratified Enrollment

Turn’s stage two design will include approximately 120 to 135 patients, including completers enrolled since the phase I portion, Burnam said. Patients will be stratified into three EASI-based groups:

• EASI 1.1 to 7, with approximately 60 patients randomized one-to-one between drug and vehicle;
• EASI 7.1 to 15.9, with approximately 60 patients randomized one-to-one;
• EASI 16 or higher, with approximately 15 patients randomized one-to-one.

Burnam said the stratification is intended to ensure comparable disease severity between treatment and vehicle arms within each category. The company will evaluate four endpoints using the Hochberg procedure: week four IGA success, week four EASI-75, week eight EASI-90 and week eight EASI-100. Burnam said the statistical approach allows multiple related endpoints to be assessed rather than spending all statistical alpha on a single primary endpoint.

Safety and Regulatory Timeline

Dr. Stephen Hahn, executive clinical and lead regulatory advisor for Turn Therapeutics, said GX-03 continues to show a favorable safety and tolerability profile based on data reviewed to date. He said there were no treatment-related serious adverse events in either treatment group in the preliminary study, no observed tolerability issues and no new safety signals.

Hahn said the second stage is governed by an independent Data and Safety Monitoring Committee. He also framed atopic dermatitis as a significant and growing disease area, citing 16.5 million adults and 9.6 million children under age 18 affected, including 3.2 million U.S. children with moderate-to-severe disease.

The company expects a stage two data readout in the fourth quarter of 2026, Hahn said. After the completed data set is available, Turn plans to use the results to inform discussions with the U.S. Food and Drug Administration, including a Type B meeting to discuss the design of a phase III trial.

Subject to a successful phase II readout, alignment with the FDA and capital availability, Hahn said Turn is targeting initiation of a phase III trial in mid-2027.

Burnam closed by saying the company is working on an FDA meeting package and hopes to complete it “within a matter of weeks” for submission to the agency using stage one data. He said Turn is seeking to advance GX-03 as quickly as possible while continuing to evaluate its potential role as a topical, non-systemic therapy for atopic dermatitis.

About Turn Therapeutics NASDAQ: TTRX

We are a pharmaceutical and medical device development company built around a proprietary platform technology designed to enhance drug performance. Our patented mixing process — commercially referred to as PermaFusion™ (“PermaFusion”) — enables stable suspension of polar, water-soluble active pharmaceutical ingredients (“APIs”) in oil-based carriers without the use of emulsifiers. This innovation reduces the quantity of required API inclusion by improving its bioavailability. Reduced API load reduces the likelihood of adverse events.

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