Clinical-stage biotechnology company Noxopharm (ASX:NOX) has successfully completed the second and final multiple-dose cohort of its SOF-SKN clinical program, marking the conclusion of the clinical phase of the HERACLES trial and delivering a highly positive safety outcome.
The independent Safety Steering Committee has confirmed that SOF-SKN was safe and well-tolerated across all dosing regimens, with no clinically relevant safety concerns identified. Noxopharm said the determination brings the entire HERACLES trial to a successful close, validating the safety profile of SOF-SKN across both single-dose and multiple-dose cohorts.
The trial advanced rapidly from participant recruitment through to completion, reflecting strong operational execution and high levels of participant compliance with both dosing requirements and topical application of the investigational cream. The pace and consistency of progress underscore the robustness of the study design and the commitment of all parties involved.
Noxopharm acknowledged the significant contribution of its clinical partners, thanking the teams at Doherty Clinical Trials, the contract research organisation, and the Hudson Institute of Medical Research for their professionalism and continued support throughout the program.
With the safety objectives of the HERACLES trial now achieved, Noxopharm is preparing to advance SOF-SKN into Phase II-enabling studies. In parallel, the company expects to initiate drug scale-up activities in the near term to support the next stage of development.
Chief Executive Officer Dr Gisela Mautner said the trial had met its primary objectives with strong results. The study was designed to assess the safety and tolerability of SOF-SKN across a range of application scenarios, and the data confirmed that the treatment performed exceptionally well on both measures. She noted that the successful execution of the trial over recent months positions the company to move confidently into its next phase, which will involve evaluating SOF-SKN in patients with lupus.
SOF-SKN is initially being developed as a topical treatment for chronic inflammation associated with cutaneous lupus erythematosus, a debilitating autoimmune skin disease. Beyond lupus, the therapy may have potential applications in other autoimmune-related dermatological conditions, including psoriasis and dermatomyositis. The global market for cutaneous lupus erythematosus alone is valued at more than US$3.3 billion and is expected to expand significantly in the coming years.