Noxopharm Limited (ASX:NOX), a clinical-stage biotechnology firm, has announced rapid progress in the recruitment phase of its HERACLES clinical trial, staying on track with its timeline.
HERACLES is a groundbreaking first-in-human study for SOF-SKN™, an innovative drug designed to treat autoimmune diseases. The trial aims to assess the safety profile of SOF-SKN across four different dosages. Conducted in Australia, the trial takes advantage of the country’s expertise in lupus research and early-phase clinical studies, while also enabling Noxopharm to claim federal R&D tax incentives.
The recruitment process encompasses a variety of activities, from promoting the trial to potential participants to conducting pre-screening and final assessments to ensure participants meet all eligibility requirements.
Initial steps in the trial have already been completed, with Noxopharm team members, Doherty Clinical Trials staff, and other involved parties undergoing mandatory training. The training covered everything from the proper handling and administration of SOF-SKN to blood sample collection, participant evaluation, and data recording.
In addition, Noxopharm has completed the manufacturing of SOF-SKN and is in the final stages of quality assurance, ensuring the drug is correctly labeled and packaged to meet regulatory standards ahead of its shipment to the trial site.
Dr. Gisela Mautner, CEO of Noxopharm, commented, “Following our recent ethics approval, we are progressing full steam ahead, handling the operational aspects of the trial. We are pleased with the swift recruitment and will keep shareholders informed as we move towards the dosing stage.”
SOF-SKN is initially being developed for cutaneous lupus erythematosus (CLE) and may eventually be expanded to treat other autoimmune-related skin conditions, such as psoriasis and atopic dermatitis. The technology behind SOF-SKN also holds potential for a broader range of diseases related to immune system dysfunction, including rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and dementia.
