Noxopharm (ASX:NOX) has contracted a specialist supplier to manufacture SOF-SKN for the upcoming HERACLES clinical trial.
SOF-SKN is a novel drug candidate for autoimmune diseases, specifically cutaneous lupus erythematosus. The first-in-human trial is planned to start in early 2025.
Noxopharm said the manufacturing contract involves highly specialised work to produce sufficient quantities of SOF-SKN at rigorous quality standards to support the trial.
SOF-SKN contains a proprietary ultra-short oligonucleotide that binds to specific inflammation receptors in the body to reduce inflammation at its source.
The company said it would take several months for enough drug to be prepared for the trial. This process will also involve Noxopharm having oversight of the full supply chain, including the procurement of high-quality raw materials that meet regulatory requirements at every step.
Once the active ingredient of the drug has been synthesised, it will then be combined with other non-active ingredients by the same manufacturer to produce the actual SOF-SKN formulation that will be applied to the skin of trial participants.
Noxopharm CEO Dr Gisela Mautner said, “Signing this contract is a commitment on our part that takes us a significant step closer to the clinic. Manufacturing such ultra-short oligonucleotides requires considerable expertise, and we are confident that our partner will deliver on time and to the high quality standards needed to support a trial in Australia.”