• First trial participant receives novel treatment
• Focus on safety, tolerability and dose-finding
• Four cohorts at ascending doses
• Addressing unmet clinical needs in global US$3 billion-plus lupus market

Noxopharm Limited, a clinical-stage Australian biotech company, has announced a major milestone with the first SOF-SKN dose administered in the HERACLES trial. 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. The first part of the trial involves four cohorts each with four participants, and a schedule of dose increases from one cohort to the next. The first cohort is now receiving the lowest dose, and a safety steering committee meeting will be held to evaluate the data and determine the next step in the trial. Noxopharm CEO Dr Gisela Mautner stated that this is a significant milestone for the company as they have taken their first Sofra drug candidate into the clinic at a rapid pace, and to their knowledge, this is the first time a molecule that blocks TLR7/8 in a targeted manner has been used topically in humans, which makes it even more exciting. The global lupus market is worth more than US$3 billion and is expected to grow significantly over the coming years.

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