First dose in HERACLES clinical trial Part Two
| Stock | Noxopharm Ltd (NOX.ASX) |
|---|---|
| Release Time | 17 Nov 2025, 8:27 a.m. |
| Price Sensitive | Yes |
First dose in HERACLES clinical trial Part Two
- Daily SOF-SKN™ dosing begins
- Repeated applications reflect real-world conditions
- Global cutaneous lupus market worth over US$3.3 billion
Noxopharm Limited (ASX:NOX) has announced the first dosing in the second part of the HERACLES clinical trial for its drug candidate SOF-SKN™, a novel treatment for autoimmune diseases. The double-blind and placebo-controlled Phase I trial aims to evaluate the safety and tolerability profile of SOF-SKN by testing it at different concentrations. This second part of the trial involves multiple daily doses of SOF-SKN being given to two cohorts in succession, with the first cohort receiving a lower dose and the second cohort receiving a higher dose. The primary goal is to ensure SOF-SKN is safe over repeated applications, as well as investigate participant tolerance and measure various pharmacokinetic and pharmacodynamic parameters. SOF-SKN is initially being developed for autoimmune diseases like cutaneous lupus erythematosus (CLE), with the global CLE market worth more than US$3.3 billion and expected to grow significantly. The Sofra™ technology platform behind SOF-SKN has potential applications in a wide range of diseases related to the immune system.
The momentum we have built up over recent months is now continuing, and we are very pleased that dosing has begun on a daily basis. This second part of the trial will produce more data that will strengthen our data package and enhance our position in regard to the upcoming regulatory approval process.