Posted: 6 November 2025
Noxopharm Limited announced it had commenced the second part of its HERACLES clinical trial, following the successful completion of single-dose testing of its novel autoimmune therapy candidate, SOF-SKN™.
Chief Executive Officer Dr Gisela Mautner said the company was now moving to assess the therapy’s safety and tolerability over repeated applications. “Now that we have successfully applied SOF-SKN in single doses to healthy volunteers, we are ramping up the testing to ensure it is safe across repeated doses. This is a vital aspect of the drug development process as regulatory authorities have strict safety approval processes for when and how new drugs are allowed to be given to people,” she said.
The first-in-human study, conducted in Australia in collaboration with Doherty Clinical Trials in Melbourne, is designed to evaluate SOF-SKN at different concentrations. The local setting enables Noxopharm to leverage Australia’s expertise in lupus research and early-phase clinical trials while accessing federal R&D tax benefits.
Following positive safety outcomes from the initial single-dose study, the Safety Steering Committee approved skipping the two lowest dose levels and starting at the second-highest dose. The second part of the trial will therefore include two cohorts of four participants each, with daily applications of SOF-SKN for two weeks and an increased dose between cohorts.
The multiple-dose regimen is intended to more closely replicate real-world use by patients with cutaneous lupus erythematosus (CLE) – a chronic autoimmune disease that may require ongoing treatment. The study will measure safety, tolerability, and pharmacokinetic and pharmacodynamic (PK/PD) parameters through electrocardiograms, physical exams, blood tests, and skin scoring assessments.
Each cohort’s dosing and readouts are expected to take about one month, after which results will be reviewed by the Safety Steering Committee before progressing to the next stage.
SOF-SKN is being developed initially for autoimmune skin diseases such as CLE, a market valued at more than US$3.3 billion, with potential applications in psoriasis, dermatomyositis, rheumatoid arthritis, and diabetes.
