Noxopharm (ASX:NOX) has reached a significant milestone in its first-in-human trial of SOF-SKN, announcing that the initial multiple-dose cohort in the HERACLES study has been completed with no safety concerns identified.
The company said it will now advance to the second and final cohort, which will receive the highest approved dose of the experimental therapy.
The Safety Steering Committee confirmed the topical drug was safe and well tolerated, with “no clinically relevant issues” emerging from the first group of participants. The safety profile allows the trial to escalate to testing a higher concentration across repeated applications, conditions designed to closely mirror real-world use for patients with chronic autoimmune skin diseases.
HERACLES, a double-blind, placebo-controlled Phase 1 study, is evaluating SOF-SKN, a novel therapy initially targeting cutaneous lupus erythematosus (CLE), a debilitating autoimmune disease for which no cure exists. Conducted in Australia, the trial leverages local expertise in lupus research and early-phase clinical development, while also enabling Noxopharm to access federal R&D tax incentives.
The trial’s second phase involves two sequential cohorts, each comprising four participants who will apply SOF-SKN once daily for two weeks. The intensive dosing schedule is intended to test how the drug performs under the conditions patients would likely face if prescribed SOF-SKN long-term to manage symptoms.
The primary objective is to confirm the safety of repeated dosing, assess tolerability, and gather detailed pharmacokinetic and pharmacodynamic data. Across the study, participants undergo a rigorous suite of assessments, including ECGs, physical examinations, blood tests, symptom questionnaires and skin scoring, to build a comprehensive understanding of the therapy’s effects over time.
SOF-SKN is being developed as a targeted immunomodulatory therapy for CLE before potential expansion into other autoimmune-related skin conditions such as psoriasis and dermatomyositis. Noxopharm also sees broader potential for its underlying Sofra technology in conditions like rheumatoid arthritis, diabetes, and other diseases driven by immune system dysregulation.