Noxopharm (ASX:NOX) has reached a new milestone in its development of SOF-SKN, announcing that the first dose has now been administered in Part Two of the HERACLES clinical trial.
The Phase 1 study, conducted in Australia, marks the first-in-human evaluation of the company’s novel topical drug candidate, designed for autoimmune skin diseases, including cutaneous lupus erythematosus (CLE).
SOF-SKN is being trialled under a double-blind, placebo-controlled design to determine its safety and tolerability across multiple concentrations. Conducting the trial domestically enables Noxopharm to leverage Australia’s extensive expertise in lupus research and early-stage clinical development, while also securing federal R&D tax incentives that support local innovation.
The newly commenced second part of the study involves multiple daily doses administered across two sequential cohorts. Each cohort comprises four participants who will apply SOF-SKN once daily for 14 days. The first cohort will receive a lower concentration, after which a Safety Steering Committee will review the data and approve the commencement of the higher-dose cohort.
Noxopharm states that the structure of Part Two is designed to replicate the real-world application of topical treatments for chronic autoimmune skin conditions. With no cure for CLE, many patients would likely require ongoing use of a therapy like SOF-SKN™ to manage symptoms, making repeated-application safety testing essential.
Working with Doherty Clinical Trials in Melbourne, the Noxopharm team will examine not only the safety of daily dosing but also participant tolerance and a broad range of pharmacokinetic and pharmacodynamic measures. The protocol involves an extensive assessment over several weeks for each cohort, including electrocardiograms, blood work, physical examinations, skin scoring, questionnaires, and repeated observational checks.
Noxopharm CEO Dr Gisela Mautner said the trial is gathering significant momentum as the program advances toward regulatory engagement.
“The momentum we have built up over recent months is now continuing, and we are very pleased that dosing has begun on a daily basis,” she said. “This second part of the trial will produce more data that will strengthen our data package and enhance our position in regard to the upcoming regulatory approval process.”
SOF-SKN is the lead program emerging from the company’s Sofra technology platform, initially targeting cutaneous lupus before potential expansion into other autoimmune and immune-related skin diseases such as psoriasis and dermatomyositis. The global CLE market, currently valued at more than US$3.3 billion, is projected to grow significantly in the years ahead as demand for more effective and better-tolerated treatments increases.