Noxopharm Ltd (ASX:NOX) has advanced its Phase One HERACLES clinical trial of SOF-SKN™, confirming that the first multiple-dose cohort has been completed with no clinically significant safety concerns. The company said the Safety Steering Committee found the treatment to be safe and well tolerated.
With the first cohort completed, the study will now move to the second and final group of participants, who will receive multiple doses at the highest level approved for this trial. Each cohort comprises four participants who receive a daily application of SOF-SKN for a two-week period.
HERACLES is the first-in-human study of SOF-SKN, a new drug candidate intended for autoimmune conditions such as cutaneous lupus erythematosus. The double-blind, placebo-controlled Phase One trial is being conducted in Australia, allowing Noxopharm to draw on local expertise in lupus research and early-stage clinical work, as well as federal research and development tax incentives.
Design reflects real-world topical use
The multiple-dose component of the trial is structured to replicate real-world use of topical therapies for chronic skin diseases, where long-term or repeated application is common. The primary objective is to assess safety under repeated dosing, supplemented by evaluations of tolerability and a range of pharmacokinetic and pharmacodynamic parameters.
Each cohort undergoes several weeks of monitoring and testing. This includes electrocardiograms, physical examinations, participant questionnaires, extensive blood sampling, and skin observation and scoring assessments conducted at multiple time points.
Broader potential for Sofra™ platform
SOF-SKN is being developed initially for cutaneous lupus, with potential to extend into autoimmune-related skin conditions such as psoriasis and dermatomyositis. The underlying Sofra™ platform is based on short nucleic acid sequences designed to modulate immune activity at its source, and may have wider application in diseases linked to immune dysregulation, including rheumatoid arthritis, diabetes and certain cancers.
The global market for cutaneous lupus treatments is valued at more than US$3.3 billion and is expected to grow, while the wider autoimmune disease therapeutics market exceeded US$163 billion in 2024.