• Second dose cohort of SOF-SKN™ completed successfully
• Next cohort to receive higher dose of SOF-SKN™
• Focus on safety, tolerability and dose finding

Noxopharm Limited (ASX:NOX) has announced the successful completion of the second dose cohort of SOF-SKN™ in the HERACLES clinical 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 now proceed to the third cohort of participants, who will receive a higher dose of SOF-SKN™. 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 incremental dose increases are a standard approach for Phase 1 trials, with the main purposes of minimizing risk for participants and determining the optimal dose to carry forward into subsequent trials. This stepwise approach helps to derisk the SOF-SKN program and ensure the best possible data is generated. SOF-SKN is initially being developed for autoimmune diseases like cutaneous lupus erythematosus (CLE) before potential development for other autoimmune-related skin diseases. The global CLE market is worth more than US$3.3 billion and is expected to grow significantly in the coming years.

The HERACLES trial will now proceed to the third cohort, where participants will receive a higher dose of SOF-SKN™. The focus of the trial remains on evaluating the safety and tolerability profile of the drug candidate.