Australian biotechnology company Noxopharm has received approval from the Human Research Ethics Committee to proceed with the HERACLES clinical trial, marking a significant milestone for the company's novel drug candidate SOF-SKN. The first-in-human study will evaluate the safety and tolerability of SOF-SKN in patients with cutaneous lupus erythematosus (CLE), a chronic inflammatory skin condition.
Trial Design and Objectives
The HERACLES trial is designed as a Phase 1 safety study that will test SOF-SKN at four different concentrations. The study represents the inaugural clinical trial from Noxopharm's Sofra technology platform, transitioning the drug candidate from extensive preclinical testing into human trials for the first time.
The trial will specifically target cutaneous lupus erythematosus, an autoimmune disease that causes characteristic skin lesions and represents an area of significant unmet medical need. By focusing on this indication, Noxopharm aims to address the limited treatment options available for patients suffering from this chronic inflammatory condition.
Strategic Partnership and Location
Noxopharm has partnered with Doherty Clinical Trials, a specialist not-for-profit organization established by the Peter Doherty Institute for Infection and Immunity, to conduct the trial in Melbourne. This collaboration capitalizes on Australia's recognized expertise in inflammatory disease research and early-phase clinical trials.
Dr Andrew Brockway, CEO of Doherty Clinical Trials, expressed enthusiasm for the partnership, stating, "We are passionate about the development of new medicines for diseases with unmet medical needs and are excited to support Noxopharm through our extensive know-how and network of collaborators."
Regulatory Progress and Timeline
The ethics approval followed what the company described as a straightforward review process, reflecting the thoroughness of the regulatory submission. Noxopharm will work closely with the Doherty Clinical Trials team to expedite operational aspects including site initiation, preparation and shipping of trial-specific SOF-SKN batches, and participant screening and recruitment.
Dr Gisela Mautner, CEO of Noxopharm, highlighted the significance of this regulatory milestone: "The granting of ethics approval for the first ever clinical trial from our Sofra technology platform is an important milestone. The quick approval is testament to the thorough preparation of the dossier by our team and also a very efficient review process by the committee, for which we are very grateful."
Development Timeline and Future Outlook
The rapid progression from preclinical development to clinical trial approval demonstrates Noxopharm's systematic approach to drug development. Dr Mautner noted that the team has "rapidly developed this drug, successfully navigated its way through extensive preclinical testing, and prepared a robust data package that has now culminated in the trial."
With detailed planning already in place, Noxopharm expects to initiate the trial quickly following the ethics approval. The company has committed to providing regular updates to shareholders as the trial activities progress, marking what Dr Mautner described as "an exciting time" for the organization.
