Highlights:

• First-in-human clinical trial for SOF-SKN™ and Sofra™ platform
• Efficient trial design with early results expected
• Leverages Australian expertise and government incentives
• Plan to expand Sofra platform for broader autoimmune disease markets

The trial, slated to begin in early 2025, marks a significant milestone for Noxopharm as it provides proof of concept for SOF-SKN in treating CLE, a chronic skin condition. The study, named HERACLES (Harnessing Endogenous Regulators Against CLE Study), will be conducted in Australia, leveraging the country’s renowned expertise in lupus research and early-phase clinical trials. By conducting the trial locally, Noxopharm will also benefit from the Australian Government’s R&D Tax Incentive scheme, maximizing the financial efficiency of the trial.

Paving the Way for Broader Market Opportunities

Noxopharm views the development of SOF-SKN as the first step in utilizing the broader potential of the Sofra™ platform to address larger autoimmune disease markets, such as rheumatoid arthritis. The Sofra™ technology platform has already garnered international attention, with several material transfer agreements in place with companies ranging from mid-size to multi-billion-dollar enterprises.

SOF-SKN is a first-in-class oligonucleotide TLR7/8 antagonist with the potential to revolutionize the treatment of CLE by targeting the disease at its source rather than merely managing its symptoms. The upcoming HERACLES trial will focus on safety and dose-finding in healthy volunteers through a structured, sequential dosing process.

A Thoughtful and Accelerated Clinical Approach

The HERACLES trial is designed to be implemented efficiently, with the first safety readouts expected within four to six weeks after dosing completion. A comprehensive data analysis is anticipated by Q4 2025. As part of the trial preparations, Noxopharm is finalizing the specific formulation of SOF-SKN to be used, alongside selecting a Phase 1 trial unit and completing other necessary pre-trial activities.

In parallel with the HERACLES trial, Noxopharm is planning a seamless transition to a follow-on study targeting lupus patients at specialist centers in Australia, further extending the clinical reach of SOF-SKN.

CEO Remarks

Dr. Gisela Mautner, CEO of Noxopharm, commented: “This trial signifies Noxopharm’s return to the clinical trial stage, a major milestone achieved in record time. We are thrilled to advance SOF-SKN, the first asset from our promising Sofra platform, into the clinic. Our methodical approach ensures we adhere to the highest standards as we embark on this critical phase of drug development. While we recognize the challenges ahead, we are committed to advancing rapidly and strategically to realize the full potential of our platform across larger markets.”

Unmet Needs in Autoimmune Disease Treatment

Autoimmune diseases, including lupus, represent a significant unmet medical need, affecting millions globally. The current treatment landscape for lupus is limited to symptom management, highlighting the immense commercial potential for SOF-SKN as a disease-modifying therapy. Lupus, commonly diagnosed in young adults, lacks a cure, making ongoing symptom treatment a lifelong necessity for many patients.

As the global immunology market continues to grow, Noxopharm is positioned to address these critical gaps with innovative solutions like SOF-SKN, offering hope to millions of patients worldwide.