• HERACLES clinical trial enters next level
• Multiple SOF-SKN doses to be given
• Successful safety results allow two lowest doses to be skipped
• Global cutaneous lupus market worth over US$3.3 billion

Noxopharm Limited (ASX:NOX) is pleased to announce the start of the second part of the HERACLES clinical trial, following successful single-dose testing. 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 different concentrations, and is taking place in Australia to capitalise on Australian expertise in lupus research and early phase clinical trials. The trial will now see multiple doses of ascending concentrations of SOF-SKN given to participants in order to continue safety testing at a more intensive level over a longer period of time. Because SOF-SKN was safe and well tolerated at all dose levels in the successful first part of the trial, the Safety Steering Committee decided it was unnecessary to test the two lowest doses in the second part, but rather begin at the second-highest dose. Skipping the two lowest dose cohorts means the trial will conclude more quickly and be more cost effective. SOF-SKN is initially being developed 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 utilised for rheumatoid arthritis and diabetes, plus other diseases linked to the dysregulation of the immune system.