Turn Therapeutics’ stock has jumped by 26% after its atopic dermatitis (AD) candidate boasted clinically meaningful efficacy in a Phase II trial, prompting the company to expand the study.
The Phase II trial (NCT07355075) is evaluating GX-03, which is a small-molecule cationic biocide of benzalkonium chloride and polyhexamethylene biguanide (PHMB). It acts as an interleukin (IL)-36/IL-31 inhibitor.
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Interim analysis from a 32-patient 1.1-to-7.0 Eczema Area and Severity Index (EASI) subgroup reached statistical significance on IGA. In the group, 14 patients received GX-03 while 18 received an inactive vehicle control.
After four weeks, validated investigator global assessment for AD (vIGA-AD) improvement was achieved in 71.4% of treated patients compared to 33.3% in the control group. EASI-100 was achieved in 28.6% of patients treated with GX-03 compared with 5.6%. This same endpoint was achieved by 35.7% of patients who received the study drug after eight weeks compared with 11.1% on the vehicle regimen.
This follows previous interim data from the first 50 patients on 1 June, which found that 92.6% of GX-03-treated subjects achieved at least a 50% reduction in overall eczema severity within four weeks (EASI-50) compared to 65.2% for vehicle-treated subjects. At four weeks, EASI-90 responses were 44.4% for GX-03 versus 30.4% for vehicle, which further increased to 51.9% versus 34.8%, respectively, by week eight.
To date, no treatment-related serious adverse events (TRSAEs) have been observed in either treatment group, and no treatment-related tolerability issues or study discontinuations have been reported.
Data supports expansion of Phase II trial
This data helps to support the progression of the company’s Phase II trial and confirms the stage two trial design. The review identified clinically meaningful efficacy across a broader spectrum of atopic dermatitis severity than the company had originally anticipated. The stage two data will serve as the primary efficacy phase supporting future regulatory development.
The stage two design will enrol approximately 120-135 patients who will be stratified into three baseline EASI severity groups (1.1-7.0, 7.1-15.9 and ≥16). Turn Therapeutics will employ prospective evaluation of four prespecified efficacy endpoints using the Hochberg multiple testing procedure: week four vIGA-AD success, week four EASI-75, week eight EASI-90 and week eight EASI-100.
“The purpose of a staged, adaptive clinical trial is to learn from the first stage to strengthen the second,” said Bradley Burnam, CEO of Turn Therapeutics. “GX-03 demonstrated meaningful activity across a wider spectrum of AD severity than we originally anticipated. We believe the optimised stage two design strengthens the current study while generating data that could support broader development and future labelling opportunities for GX-03.”
Following this announcement, the company’s stock rose by 26.27%, from a 6 July close of $7.69 to a 7 July close of $9.71. The company, listed on the Nasdaq, has a market cap of $289.24m.
AD competition fierce
While the data has impressed investors, the AD market is fierce and has several blockbuster drugs.
This includes Sanofi and Regeneron’s Dupixent (dupilumab), which brought in €15.7bn ($17.9bn) for the big pharma company in 2025 alone, and is considered the gold standard for the treatment of moderate to severe AD. The drug is approved across a large number of indications, including AD, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD), among others.
While Dupixent’s reign may be coming to an end as it approaches patent expiry in 2031, Sanofi has already completed late-stage development for what it hopes will be the drug’s successor, amlitelimab. The Phase III trial met one of its co-primary endpoints of the proportion of US and US reference country patients achieving vIGA-AD 0/1, and a ≥2-point reduction in vIGA-AD after 24 weeks. However, the drug narrowly missed its EU and EU reference country co-primary endpoint, which required a significant proportion of patients to reach vIGA-AD 0/1, as well as EASI-75.
GlobalData estimates that the AD market will grow from $8.5bn in 2023 to $22.4bn by 2033 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). GlobalData is the parent company of Clinical Trials Arena.
Speaking in June 2025 at the time of GlobalData’s report, Filippos Maniatis, healthcare analyst at GlobalData, said: “AD is a growing market with an impressive pipeline of new products from current and future players in the field. The AD space was previously dominated by broad-acting immunomodulatory agents, which are now being slowly replaced by more targeted agents. This shift is likely due to better comprehension of the pathophysiology behind AD and the approval of several new systemic agents.”
