• First multiple-dose cohort of SOF-SKN™ successfully completed
• Second and final cohort to receive highest SOF-SKN™ dose
• Repeated applications reflect real-world conditions

Noxopharm Limited (ASX:NOX) has announced the successful completion of the first multiple-dose cohort of its HERACLES trial for SOF-SKN™, a novel drug candidate for autoimmune diseases. The Safety Steering Committee has determined the treatment to be safe and well-tolerated, with no clinically relevant issues found. The trial will now proceed to the second and final cohort of participants, who will receive multiple doses at the highest level approved for this trial. HERACLES is a first-in-human trial for SOF-SKN™, which is being developed for autoimmune diseases like cutaneous lupus erythematosus (CLE) before potential development for other autoimmune-related skin diseases. The double-blind and placebo-controlled Phase I trial aims to evaluate the safety and tolerability profile of SOF-SKN by testing it at different concentrations. The repeated administrations of the drug plus subsequent readouts will take several weeks for each cohort, with a battery of tests including electrocardiograms, physical exams, participant questionnaires, numerous blood tests, and skin observation scoring tests. Noxopharm will also secure federal R&D tax benefits by conducting the study locally in Australia, capitalizing on the country's expertise in lupus research and early phase clinical trials.

Noxopharm is initially developing SOF-SKN™ for autoimmune diseases like cutaneous lupus erythematosus (CLE) before potential development for autoimmune-related skin diseases like psoriasis and dermatomyositis. The global CLE market is worth more than US$3.3 billion and is expected to grow significantly over the coming years. The core Sofra™ technology could also be further utilized for rheumatoid arthritis and diabetes, plus other diseases linked to the dysregulation of the immune system.