Noxopharm (ASX:NOX) has announced significant progress in its HERACLES trial for SOF-SKN, a promising new drug candidate for autoimmune diseases.
The company has completed the second dose cohort, with the safety steering committee determining it to be safe and tolerable. This green light allows the trial to proceed to the third cohort, where participants will receive a higher dose.
The HERACLES trial, a first-in-human study for SOF-SKN, aims to evaluate the safety and tolerability of the drug at four different concentrations.
The trial employs a stepwise approach to dose escalation, which is standard for Phase 1 trials. This method serves two essential purposes. It minimises risk for participants and helps identify the optimal dose for future clinical studies. The careful approach helps de-risk the SOF-SKN program and ensures the collection of high-quality data.
The HERACLES protocol involves four cohorts, each with four participants receiving a single dose of SOF-SKN. Each cohort undergoes extensive testing over approximately two weeks, including electrocardiograms, physical exams, and various blood and skin tests. A safety steering committee of clinical and trial experts evaluates the data before approving progression to the next, higher-dose cohort.
Noxopharm is initially developing SOF-SKN for autoimmune diseases like cutaneous lupus erythematosus (CLE), with potential expansion into other autoimmune-related skin conditions such as psoriasis and dermatomyositis. The underlying Sofra technology could also have applications in rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and even dementia.
The global market for CLE treatments alone is valued at over US$3.3 billion and is expected to grow significantly in the coming years. This presents a substantial opportunity for Noxopharm if SOF-SKN continues to show promise through its clinical development.