Noxopharm Ltd (ASX:NOX, OTC:NOXOF) has locked in a specialist manufacturer to produce its novel drug candidate, SOF-SKN™ in preparation for its upcoming HERACLES clinical trial.
The drug contains a proprietary ultra-short oligonucleotide that targets specific inflammation receptors, reducing inflammation at the source.
CEO Dr Gisela Mautner said: “Signing this contract is a commitment on our part that takes us a significant step closer to the clinic.
Considerable expertise required
“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.”
SOF-SKN is being developed to treat autoimmune diseases, specifically cutaneous lupus erythematosus (CLE), and the first human trial is set to begin in early 2025.
The manufacturing contract involves highly specialised processes to ensure the production of SOF-SKN meets the stringent quality standards required for clinical trials.
These processes, involving advanced technical and purification steps, will take several months.
Overseeing supply chain
Noxopharm will have oversight of the entire supply chain, ensuring the procurement of high-quality raw materials and compliance with regulatory requirements.
After synthesising the active ingredient, the manufacturer will combine it with non-active ingredients to create the final formulation, which will be applied to the skin of trial participants.
This manufacturing partner has previously worked on preclinical studies for SOF-SKN, reducing risks during this critical stage of the trial preparations.
Noxopharm has also thoroughly characterised the physical and chemical properties of the drug’s ingredients to ensure a consistent and replicable product for patient use.
Strict microbiological testing will be conducted to maintain the purity and quality of the formulation.
In parallel, Noxopharm is selecting a Phase 1 trial unit and preparing for other regulatory requirements necessary to begin the clinical trial.
Global unmet need
Autoimmune diseases, including lupus, affect millions of people globally. In the US alone, between 14 and 24 million people suffer from these conditions.
The global immunology market is expected to grow from US$92 billion in 2021 to US$158 billion by 2028, which serves to highlight the significant demand for innovative treatments like SOF-SKN.