HERACLES clinical trial Update 4
| Stock | Noxopharm Ltd (NOX.ASX) |
|---|---|
| Release Time | 8 Sep 2025, 9:25 a.m. |
| Price Sensitive | Yes |
Noxopharm Completes Key Milestone in HERACLES Trial
- Fourth and final single-dose cohort of SOF-SKN completed
- SOF-SKN found safe and well-tolerated at highest dose
- Global cutaneous lupus market worth over US$3.3 billion
Noxopharm Limited has announced the successful completion of the fourth and final single-dose cohort of the HERACLES trial for its drug candidate SOF-SKN. The safety steering committee has determined that the highest dose level of SOF-SKN is safe and well-tolerated, with no clinically relevant issues found. This marks an important milestone in the development of SOF-SKN as a novel drug for autoimmune diseases, as it is the first time the drug has been tested on people. The HERACLES trial is taking place in Australia to capitalize on the country's expertise in lupus research and early-phase clinical trials, and will also allow Noxopharm to secure federal R&D tax benefits. The four-cohort single-dose part of the trial has seen SOF-SKN administered to a total of 16 participants, with a schedule of dose increases from one cohort to the next. Extensive testing, including electrocardiograms, physical exams, blood tests, and skin observation scoring, was carried out at multiple time points to assess the safety and tolerability of the drug. Noxopharm CEO Dr. Gisela Mautner stated that the successful completion of this part of the trial and the absence of any safety concerns are an important achievement, and the company is now finalizing plans for the next steps of the HERACLES study. SOF-SKN is initially being developed for autoimmune diseases like cutaneous lupus erythematosus (CLE), a market worth more than US$3.3 billion and expected to grow significantly in the coming years. The Sofra technology platform, of which SOF-SKN is a part, also has potential applications in a wide range of other diseases related to the immune system, including rheumatoid arthritis, type 1 diabetes, and inflammatory bowel disease.
Noxopharm is now finalizing plans and will update shareholders soon on the next steps for the HERACLES trial of SOF-SKN, its novel drug candidate for autoimmune diseases.