• First cohort with lowest SOF-SKN™ dose completed
• Next cohort to receive higher dose
• Focus on safety, tolerability and dose finding

Noxopharm Limited (ASX:NOX) has announced the successful completion of the first dose cohort of its HERACLES trial for the novel drug candidate SOF-SKN™. The safety steering committee has determined the first dose level to be safe and tolerable, with no clinically relevant issues found. The trial will therefore now proceed to the second 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 capitalize 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. In the drug development process, a clean safety profile is of paramount importance, as any new drug can potentially have safety issues that could halt further development. Regulatory authorities have strict safety approval processes, and around 30% of new drugs fail during trials due to unmanageable toxicity. The first part of the HERACLES trial involves four cohorts, each with four participants receiving a single dose of SOF-SKN, and a schedule of dose increases from one cohort to the next. This data will then be evaluated and discussed by the safety steering committee before it can give the green light to proceed to the next cohort and a higher dose.

The core Sofra™ technology could be further utilized for a wide range of autoimmune and inflammatory diseases, including rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and other diseases linked to the dysregulation of the immune system, such as dementia.