• Second and final multiple-dose cohort of SOF-SKN successfully completed
• No clinically relevant issues found during the trial
• Preparing to begin Phase II-enabling studies and drug scale-up processes

Noxopharm Limited (ASX:NOX) has announced the successful completion of the HERACLES clinical trial for its SOF-SKN drug. The trial's second and final multiple-dose cohort has been finished, with the Safety Steering Committee determining the treatment to be safe and well-tolerated, with no clinically relevant issues found. This marks the successful conclusion of the entire clinical part of the HERACLES trial, with a highly positive safety outcome for all dosing groups. The trial has progressed rapidly from its recruitment phase through every single-dose and multiple-dose cohort to its conclusion, with high levels of participant compliance. Noxopharm CEO Dr Gisela Mautner expressed pride in the way the trial was delivered over the past few months. Following this positive safety outcome, the company expects to begin Phase II-enabling studies and drug scale-up processes in the near future. SOF-SKN is initially being developed for the chronic inflammation caused by the autoimmune disease 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 over the coming years. The core Sofra technology could also be further utilized for other diseases linked to the dysregulation of the immune system.

The company is now preparing to move forward with Phase II-enabling studies and drug scale-up processes for its SOF-SKN drug, which is initially being developed for the treatment of cutaneous lupus erythematosus (CLE).