Posted: 21 July 2025
Noxopharm has reached a significant milestone with the first dose of its novel candidate SOF-SKN™ administered in the HERACLES clinical trial, a first-in-human study targeting autoimmune skin diseases.
Designed to evaluate safety, tolerability, and optimal dosage, the HERACLES trial involves four escalating dose cohorts and is being conducted in Australia, leveraging local strengths in lupus research and early-phase clinical trials. By running the study domestically, Noxopharm will also benefit from Australian R&D tax incentives.
“This is a huge milestone for the company as we have taken our first Sofra drug candidate into the clinic at a rapid pace,” said Dr Gisela Mautner, CEO of Noxopharm. “To our 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.”
SOF-SKN™ is a topical therapeutic under development for cutaneous lupus erythematosus (CLE), with future potential applications in conditions such as psoriasis, atopic dermatitis, and broader autoimmune disorders. The company’s proprietary Sofra™ platform is also being explored for diseases driven by immune dysregulation, including rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and dementia.
The initial dosing followed extensive preparatory work including regulatory submissions, drug production and shipping, database setup, and site readiness
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