Turn Therapeutics Inc（TTRX）资讯与事件TTRXTurn Therapeutics Inc

Turn Therapeutics Publishes GX-03 Study Results, 66% Reduction in Skin Inflammatory Signals

Turn Therapeutics announced the publication of new peer-reviewed research providing in-vivo evidence that its lead investigational therapy, GX-03, selectively reduces several important inflammatory signals associated with inflammatory skin disease. The study, published in Life, showed that pretreatment with GX-03 reduced IL-36alpha and IL-36gamma release by approximately 50%. IL-36 is an important early signal in the inflammatory cascade and helps amplify inflammation in the skin. GX-03 also reduced IL-31 by nearly 68%. IL-31 is closely associated with itch in inflammatory skin diseases such as atopic dermatitis. In addition, IL-4, another important inflammatory cytokine involved in the immune response, was reduced by 16.7%. Importantly, IL-13 was essentially unchanged, suggesting that GX-03 did not suppress every inflammatory signal measured, but instead produced a selective pattern of cytokine reduction. These biological changes were accompanied by a 66% reduction in clinical dermatitis severity in GX-03-pretreated animals compared with untreated controls. The timing of the intervention is an important part of the study. Many current therapies for atopic dermatitis are designed to block inflammatory pathways after disease and inflammation are already established. In this study, researchers applied GX-03 before exposing the skin to a standardized bacterial challenge known to trigger atopic dermatitis-like inflammation. They then measured the inflammatory response that developed afterward. Animals pretreated with GX-03 developed substantially less severe dermatitis and showed significant reductions in IL-36alpha, IL-36gamma, IL-31 and IL-4. The study therefore provides a different experimental perspective on inflammatory skin disease by examining whether modifying the skin environment can change the intensity and pattern of the inflammatory response. The study evaluated 40 mice that received either no pretreatment or four days of topical GX-03 before standardized Staphylococcus aureus exposure. Following predefined exclusions, 18 animals in each group were included in the final analysis. GX-03 pretreatment reduced mean clinical disease severity from a vIGA-AD score of 2.44 in untreated animals to 0.83, representing a 66.0% reduction. IL-36alpha expression decreased by 49.9%, IL-36gamma by 50.9%, IL-31 by 67.7%, and IL-4 by 16.7%. IL-13 did not differ significantly between the groups. No local irritation, dryness, redness, barrier disruption or other adverse skin findings were observed during the GX-03 pretreatment period. The publication, titled "Effects of Extended-Release Polyhexanide on Inflammatory Cytokine Expression and Disease Severity Following Staphylococcus aureus Exposure in a Murine Dermatitis Model," was co-authored by Bradley Burnam, Chief Executive Officer of Turn Therapeutics, and Stephen D. Bresnick, M.D., an independent researcher. The study was conducted at Altogen Labs under an IACUC-approved protocol and builds upon Turn Therapeutics' previously published research in the Journal of Dermatological Treatment.

Turn Therapeutics Reports Strong Q2, GX-03 Data Exceeds Expectations

"The second quarter was one of the most productive periods in Turn Therapeutics' history. Our review of interim GX-03 Phase 2 data showed activity across a broader range of atopic dermatitis patients than anticipated, including patients with moderate-to-severe lesions despite lower EASI, or Eczema Area and Severity Index. This represents an important and underserved population that may need stronger treatment options but can be ineligible for certain advanced therapies because their disease does not affect enough of the body. These findings allowed us to refine Stage 2 around this broader population and the endpoints showing the most encouraging treatment separation. During the quarter, we also appointed Dr. Stephen Hahn to strengthen our clinical and regulatory leadership, published our first peer-reviewed preclinical data demonstrating GX-03's anti-inflammatory activity, and advanced our FDA Type B meeting package. The Phase 2 study continued uninterrupted, and we remain on track to complete enrollment by year-end," said Bradley Burnam, Chief Executive Officer of Turn Therapeutics.

Turn Therapeutics Completes Interim Analysis of GX-03 Clinical Trial

Turn Therapeuticsannounced the completion of a comprehensive interim analysis of its ongoing adaptive Phase 2 clinical trial evaluating GX-03 for the treatment of atopic dermatitis. The multi-week review resulted in the final Stage 2 study design, incorporating data-driven refinements to patient selection, disease stratification, endpoint evaluation, and statistical methodology. The review identified clinically meaningful efficacy across a broader spectrum of atopic dermatitis severity than originally anticipated, enabling expansion of the ongoing Phase 2 program to prospectively evaluate patients across the full spectrum of baseline disease severity. The comprehensive interim review confirmed preliminary observations that Week 4 provided the earliest and clearest treatment separation between GX-03 and vehicle, supporting inclusion of Week 4 efficacy endpoints in the final Stage 2 design and highlighting the potential for a rapidly acting topical therapy across the atopic dermatitis severity spectrum. In addition, GX-03 demonstrated clinically meaningful efficacy in patients with baseline Eczema Area and Severity Index - EASI - scores of 1.1 to 7.0, expanding the range of disease severity prospectively evaluated in Stage 2 beyond what was originally anticipated. Collectively, these findings supported a final Stage 2 design evaluating one unified patient population across the full baseline EASI spectrum using multiple efficacy endpoints. GX-03 continues to demonstrate a favorable safety and tolerability profile. Enrollment will continue under the final Stage 2 protocol, and Turn Therapeutics anticipates completing enrollment during Q4. The company remains sufficiently capitalized to support completion of the study and planned operations through Q3 2027.