GX-03 / Turn Therap - LARVOL DELTA

Effects of Extended-Release Polyhexanide on Inflammatory Cytokine Expression and Disease Severity Following Staphylococcus Aureus Exposure in a Murine Dermatitis Model. (PubMed, Life (Basel)) - "Pretreatment with extended-release polyhexanide (GX-03) reduced disease severity and was associated with decreased expression of IL-36α, IL-36γ, IL-31, and IL-4 following epicutaneous Staphylococcus aureus exposure, while IL-13 expression remained unchanged. These findings suggest that modulation of the cutaneous microenvironment is associated with selective alterations in inflammatory cytokine expression following microbial challenge. Additional studies incorporating microbiologic, histologic, and mechanistic endpoints are needed to further define the biological mechanisms responsible for these observations."

Journal • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • IL4

Company plans to expand GX-03 development into Hidradenitis Suppurativa (HS) (Businesswire) - "Turn Therapeutics is planning a Phase 2a study of GX-03 in hidradenitis suppurativa, or HS, a chronic inflammatory skin disease that can cause painful lumps, abscesses, and tunnels beneath the skin....The planned study is expected to enroll approximately 60 patients, with approximately half receiving GX-03 and half receiving vehicle, and will evaluate multiple established measures of HS improvement and patient-reported skin pain at various timepoints. The Company is targeting first patient enrollment in the second quarter of 2027."

New P2a trial • Hidradenitis Suppurativa

Company expands Phase 2 study after interim data show activity in a broader and potentially underserved population of atopic dermatitis patients (Businesswire) - "Based on these findings, Turn expanded Stage 2 to enroll approximately 120 to 135 patients across a broader range of overall disease extent while continuing to require moderate-to-severe lesion severity, defined as an IGA score of at least 3. The study will evaluate four efficacy endpoints using a single pre-specified statistical analysis, and based on the treatment differences observed in the interim analysis, the planned Stage 2 sample size provides at least 99.8% statistical power across the four selected endpoints. The study continued without interruption during the interim review, and the Company remains on track to complete enrollment by the end of 2026."

New P2 trial • Atopic Dermatitis • Immunology

GX-03 trial data and cash runway at Turn Therapeutics (NASDAQ: TTRX) (StockTitan.net) - "In an ongoing Phase 2 AD trial (planned N = ~ 120-135), a Stage 1 subgroup with baseline PP‑NRS ≥ 7 (GX‑03 n=13, vehicle n=12) showed week‑4 vIGA‑AD success in 61.5% of GX‑03 patients versus 8.3% on vehicle, and EASI‑75 in 69.2% versus 25.0%. Safety data include over 200,000+ patients previously treated with GX‑03 in other indications with zero reported adverse events, plus Phase 2 Stage 1 results showing only one non‑severe adverse event in each arm....Planned milestones, subject to successful completion of each phase and capital availability, include a Phase 2 AD topline readout in Q4 2026, Phase 3 initiations in AD and onychomycosis in 2027, and a Phase 2a trial in HS."

New P2a trial • New P3 trial • P2 data • Atopic Dermatitis • Hidradenitis Suppurativa • Immunology

Effects of extended-release topical polyhexanide in a Staphylococcus aureus-induced murine dermatitis model characterized by IL-36 expression. (PubMed, J Dermatolog Treat) - "Treatment with GX03 resulted in a significant reduction in disease severity, with mean global assessment scores decreasing from 3.00 in untreated controls to 1.44 in treated animals (52% reduction; p = 0.0003). These findings suggest that extended-release topical polyhexanide (GX03) reduces disease severity in a murine dermatitis model characterized by IL-36 expression."

Journal • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

The Company’s lead clinical trial, a phase 2 RCT of GX-03 for moderate-severe atopic dermatitis, remains on track. (Investing.com) - "Both interim and topline data are expected in the first half of 2026. Enrollment is continuing as expected, supporting trial timelines and statistical objectives."

P2 data • Trial status • Atopic Dermatitis

Turn Therapeutics’ GX-03 Technology Named as One of “Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment” by Patient Care Online Magazine (GlobeNewswire) - "'We are working diligently to bring our proprietary pipeline of therapeutics to market and look forward to announcing topline data from our lead program in severe eczema in early 2026.'"

Clinical data • Commercial • Atopic Dermatitis • Dermatology

Turn Therapeutics Announces Positive In-Vivo Data for Non-Melanoma Skin Cancer Candidate (PRNewswire) - "Turn Therapeutics...announced positive in-vivo data for its therapeutic candidate (GX-03) as a non-invasive treatment for Basal Cell Carcinoma (BCC)....In a large human tumor xenograft study over 30 days, GX-03 showed statistically significant inhibition of tumor growth compared to placebo. The study also incorporated a standard of care chemotherapeutic comparator arm, Fluorouracil (5-FU). In the study, GX-03 inhibited tumor growth in a numerically significant manner as compared to 5-FU, as well."

Preclinical • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor