Posted: 14 August 2025
Noxopharm Limited is has announced the second dose cohort of SOF-SKN™ has been successfully completed in the HERACLES trial.
The safety steering committee has determined the second dose level to be safe and tolerable, with no clinically relevant issues found. The trial will therefore now proceed to the third cohort of participants, who will receive a higher dose.
HERACLES is a first-in-human trial for SOF-SKN™, a novel drug candidate for autoimmune diseases. The study aims to evaluate the safety and tolerability profile of SOF-SKN by testing it at four different concentrations, and is taking place in Australia to capitalise on Australian expertise in lupus research and early phase clinical trials. Noxopharm will also secure federal R&D tax benefits by conducting the study locally.
SOF-SKN is initially being developed for autoimmune diseases like cutaneous lupus erythematosus (CLE) before potential development for autoimmune-related skin diseases like psoriasis and dermatomyositis. The core Sofra™ technology could also be further utilised for rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease and other diseases linked to the dysregulation of the immune system, such as dementia.
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