• Third dose cohort of SOF-SKN™ completed successfully
• Next cohort to receive highest dose approved for the trial
• Double-blind study with standardized processes to ensure quality

Noxopharm Limited, a clinical-stage Australian biotech company, has announced the successful completion of the third dose cohort of SOF-SKN™ in the HERACLES clinical trial. The safety steering committee has determined the third dose level to be safe and well-tolerated, with no clinically relevant issues found. The trial will now proceed to the fourth cohort, where participants will receive the highest dose approved for the study. 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. The trial is taking place in Australia to capitalize on the country's expertise in lupus research and early-phase clinical trials, as well as to secure federal R&D tax benefits. The HERACLES trial is a double-blind study, where neither the participants nor the researchers directly involved know which cream is SOF-SKN and which is a placebo. This approach is designed to reduce potential bias and mitigate factors not directly related to the treatment itself. The first part of the trial involves four cohorts, each with four participants receiving a single dose of SOF-SKN, with a schedule of dose increases from one cohort to the next. Safety is of paramount importance in the drug development process, as regulatory authorities have strict approval processes to limit toxicity risks to clinical trial participants. SOF-SKN is initially being developed for autoimmune diseases like cutaneous lupus erythematosus (CLE), with the potential for further development in other autoimmune-related skin diseases and conditions linked to the dysregulation of the immune system.

The global CLE market is worth more than US$3.3 billion and is expected to grow significantly over the coming years. The global autoimmune disease therapeutics market was worth US$163.2 billion in 2024 and is expected to reach US$219.6 billion by 2035, while the worldwide immuno-oncology market was US$43 billion in 2023 and is projected to hit US$284 billion by 2033.