Australian clinical-stage biotechnology company Noxopharm (ASX:NOX) has commenced the second part of its HERACLES clinical trial, marking another milestone in the development of SOF-SKN, a novel topical therapy targeting autoimmune skin diseases such as cutaneous lupus erythematosus (CLE).
The HERACLES study, being conducted in collaboration with Doherty Clinical Trials in Melbourne, is the first-in-human evaluation of SOF-SKN. Following successful single-dose testing earlier this year, the trial will now move into a multiple-dose phase to further assess the drug’s safety, tolerability, and pharmacological behaviour under conditions that more closely reflect real-world use.
Noxopharm CEO Dr Gisela Mautner said the progression into the next stage of testing represented an important step in validating the company’s autoimmune platform. “Now that we have successfully applied SOF-SKN in single doses to healthy volunteers, we are ramping up testing to ensure it is safe across repeated doses,” Dr Mautner said. “This is a vital aspect of the drug development process, as regulatory authorities have strict safety requirements for how and when new therapies can be administered.”
The company confirmed that the trial’s Safety Steering Committee had approved skipping the two lowest dose levels tested in Part A, allowing researchers to begin the next stage at a higher concentration. The decision, made based on favourable safety data, will make the study more efficient and cost-effective, reducing timelines while maintaining scientific rigour.
In the new phase, participants will receive daily applications of SOF-SKN over two weeks, with each cohort increasing the dosage as safety data permit. The study involves intensive monitoring, encompassing electrocardiograms, blood analyses, skin scoring, and participant questionnaires, conducted across multiple time points.
SOF-SKN is being developed for cutaneous lupus, a chronic and incurable autoimmune condition that causes painful and disfiguring skin lesions. The global market for CLE therapies is estimated at more than US$3.3 billion, with demand expected to grow as new targeted treatments emerge.
Beyond CLE, Noxopharm believes its Sofra technology platform, from which SOF-SKN is derived, could be extended to other immune-related diseases such as psoriasis, dermatomyositis, rheumatoid arthritis, and diabetes. The platform’s short oligonucleotide-based compounds are designed to regulate inflammation at its source by mimicking natural immune control mechanisms present in healthy individuals.
Dr Mautner said the company remains focused on leveraging Australia’s clinical research strengths while securing local R&D tax benefits to support early-stage development. “Australia continues to be a global leader in early clinical research, and our collaboration with Doherty Clinical Trials allows us to combine world-class scientific expertise with a highly efficient regulatory framework,” she said.