Posted: 26 August 2025
Noxopharm Limited announced that the third dose cohort of its first-in-human HERACLES trial evaluating SOF-SKN™, a novel drug candidate for autoimmune diseases, had been successfully completed.
The company confirmed that the safety steering committee found the third dose level to be safe and well tolerated, with no clinically significant issues reported. As a result, the study would progress to the fourth and final cohort, in which participants will receive the highest dose permitted under the trial protocol.
HERACLES is being conducted in Australia to leverage national expertise in lupus research and early-stage clinical testing, as well as to secure federal R&D tax benefits. The study’s design involves four dose-escalating cohorts, each comprising four participants, with data from electrocardiograms, physical examinations, blood tests, skin scoring assessments and questionnaires analysed before clearance to advance to the next dose level.
The trial is double-blind, with participants receiving both SOF-SKN and a placebo cream, applied randomly to opposite sides of their backs. This method, considered the gold standard in clinical research, ensures neither the participants nor clinicians know which side received the active treatment, thereby reducing bias and eliminating the need for a separate control group.
Noxopharm highlighted that safety remained paramount in early-phase trials, given that around 30% of new drugs fail due to toxicity issues. Regulatory approval processes require substantial safety data before further clinical development can proceed.
The company noted that SOF-SKN was initially being developed for cutaneous lupus erythematosus (CLE), with potential future applications in autoimmune-related skin conditions such as psoriasis and dermatomyositis. The Sofra™ platform underpinning SOF-SKN could also be extended to systemic autoimmune diseases including rheumatoid arthritis, type 1 diabetes and inflammatory bowel disease.
Noxopharm said the global CLE market, currently valued at over US$3.3 billion, was expected to expand substantially, presenting a significant commercial opportunity for the drug if successfully developed.
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