Posted: 2 June 2025
BioMelbourne Network is pleased to share that one of our valued members, Noxopharm Limited (ASX:NOX), has received approval from the Human Research Ethics Committee for the HERACLES clinical trial. This approval follows a straightforward review process, allowing the company to begin recruitment activities promptly.
HERACLES will be the first-in-human trial of SOF-SKN™, a novel drug candidate designed to treat chronic inflammatory diseases. The trial aims to evaluate the safety profile of SOF-SKN by testing it at four different concentrations. Conducting the study in Australia will leverage local expertise in inflammatory disease research and early phase clinical trials, while also securing federal R&D tax benefits.
With the green light, Noxopharm will collaborate closely with the Doherty Clinical Trials team in Melbourne to advance the operational aspects of the trial. This includes site initiation, preparation and shipment of trial-specific batches of SOF-SKN, and screening and recruiting participants.
The Doherty Clinical Trials team is renowned for its extensive experience with leading clinical investigators and research scientists, particularly in early phase studies. Their deep knowledge in clinical trials, infectious diseases, and immunology will be instrumental in the success of HERACLES.
Dr. Gisela Mautner (below), CEO of Noxopharm, stated, “The granting of ethics approval for the first clinical trial from our Sofra™ technology platform is a significant milestone. The quick approval reflects the thorough preparation by our team and the efficient review process by the committee. We are grateful for this support.”
Dr Gisela Mautner
CEO and Managing Director of Noxopharm
Dr. Mautner added, “Our team has rapidly developed this drug, navigated extensive preclinical testing, and prepared a robust data package culminating in the trial. We have planned everything in great detail and will start the trial very quickly. It’s an exciting time, and we will keep shareholders updated as these activities progress.”
SOF-SKN is initially targeted at cutaneous lupus erythematosus (CLE) with potential development for autoimmune-related skin diseases like psoriasis and atopic dermatitis. The Sofra technology could also be applied to rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and other diseases linked to immune system dysregulation, such as dementia.
BioMelbourne Network members are constantly at the forefront of innovation in health technologies, be it Victoria, Australia, and beyond. We are pleased to share this exciting development from Noxopharm and will continue to share further updates as they continue to advance within the industry.
For the full press release, click here.
About Noxopharm
Noxopharm Limited (ASX:NOX) is a clinical-stage Australian biotech company discovering and developing novel treatments for cancer and inflammation, including a pioneering technology to improve the safety profile of a wide range of mRNA medicines.
The company utilises specialist in-house capabilities and strategic partnerships with leading researchers to build a growing pipeline of new proprietary drugs based on two technology platforms – Sofra™ (inflammation, autoimmunity, mRNA drug enhancement, and oncology) and Chroma™ (oncology).
To learn more, please visit: noxopharm.com
