Ethics Approval Paves Way for Noxopharm’s Risky First-in-Human Trial
Noxopharm has secured ethics approval to commence the HERACLES trial, marking the first human study of its novel SOF-SKN™ drug aimed at chronic inflammatory diseases.
- Human Research Ethics Committee approves HERACLES trial
- First-in-human study of SOF-SKN™ drug candidate
- Trial to test safety at four dosage levels
- Recruitment and trial operations to begin in Australia
- Initial focus on cutaneous lupus erythematosus with broader autoimmune potential
Ethics Approval Clears Path for HERACLES Trial
Australian biotech firm Noxopharm Limited has received prompt approval from the Human Research Ethics Committee to initiate its HERACLES clinical trial. This milestone clears the way for the company’s first-in-human study of SOF-SKN™, a novel drug candidate designed to address chronic inflammatory diseases. The approval reflects both the thorough preparation by Noxopharm’s team and an efficient review process, setting the stage for rapid trial commencement.
Trial Design and Strategic Location
The HERACLES trial will evaluate the safety profile of SOF-SKN™ by administering four different concentrations to participants. Conducted in Australia, the study leverages the country’s strong expertise in inflammatory disease research and early-phase clinical trials. Additionally, running the trial locally allows Noxopharm to benefit from federal research and development tax incentives, supporting the company’s financial and operational strategy.
Collaboration with Doherty Clinical Trials
Noxopharm will collaborate closely with the Doherty Clinical Trials team in Melbourne, known for its extensive experience in early phase studies and immunology. This partnership is expected to accelerate operational activities such as site initiation, drug batch preparation, and participant recruitment. The Doherty team’s expertise in infectious diseases and immune system disorders aligns well with the trial’s focus.
Targeting Lupus and Beyond
SOF-SKN™ is initially targeted at cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. However, Noxopharm envisions broader applications for the drug, including other autoimmune-related skin diseases like psoriasis and atopic dermatitis. The underlying Sofra™ technology platform also holds promise for treating rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and even neurological conditions linked to immune dysregulation such as dementia.
Looking Ahead
CEO Dr Gisela Mautner expressed optimism about the milestone, emphasizing the company’s detailed planning and readiness to commence the trial swiftly. While the path ahead involves significant work, this approval marks a critical step in translating Noxopharm’s innovative science into potential new therapies for patients with inflammatory and autoimmune diseases.
Bottom Line?
With ethics approval secured, Noxopharm is poised to advance SOF-SKN™ from lab to clinic, signaling a pivotal moment for its inflammation drug pipeline.
Questions in the middle?
- How quickly will patient recruitment progress and what are the expected timelines for initial safety data?
- What are the specific criteria for selecting trial participants across the four dosage groups?
- How might early safety results influence the development pathway for other autoimmune indications?
