Noxopharm has announced that its lead experimental therapy, SOF-SKN, will advance to an extension clinical study in patients with cutaneous lupus erythematosus, a painful and disfiguring skin condition for which no targeted treatment currently exists.
The Sydney-based company said the new study is planned to begin in Australia in the first quarter of calendar year 2027, pending completion of regulatory and contractual requirements, including ethics approval.
The trial will take place in Melbourne and will enrol approximately 15 patients with cutaneous lupus erythematosus, each of whom will receive 14 days of daily topical dosing with SOF-SKN followed by a seven-day follow-up period.
Lupus is an autoimmune disease that can affect multiple organs, and cutaneous lupus erythematosus is the subtype that manifests on the skin. According to the company, there is a significant unmet need for targeted, well-tolerated therapies, and the disease represents a potential opportunity for Orphan Drug Designation given the lack of current targeted treatments.
The extension study follows the successful completion of a first-in-human trial of SOF-SKN in healthy volunteers in January 2026, known as the HERACLES Phase I trial. The new study is designed to assess the therapy's safety and tolerability in patients with cutaneous lupus erythematosus, while also generating initial signals of clinical efficacy.
Noxopharm said it expects to complete patient recruitment and treatment and report initial efficacy signals in the second quarter of calendar year 2027. A full clinical data readout, including efficacy signals and safety and tolerability data, is anticipated in the fourth quarter of that year. The data is intended to inform the design of the company's planned Phase II clinical trial in patients with cutaneous lupus erythematosus, targeted for the first half of calendar year 2028, subject to regulatory feedback and standard clinical and manufacturing requirements.
Associate Professor Amanda Saracino, a clinical and academic dermatologist who specialises in autoimmune connective tissue diseases and skin manifestations of autoimmune disease, will lead the planned study and leads specialist clinics and a broad array of research activities in Melbourne.
Associate Professor Saracino said, "As a clinician who regularly treats people with lupus and other skin diseases, I am eager to assess SOF-SKN in patients with CLE. While SOF-SKN uses a well-recognised signalling pathway (TLR7/8 inhibition) for therapies in development for autoimmune conditions, its novel topical delivery approach has the potential to offer hope to CLE patients and others with a variety of chronic inflammatory skin diseases."
SOF-SKN is developed using Noxopharm's proprietary Sofra platform, which the company describes as translating naturally occurring immune control into targeted medicines. The broader Sofra technology platform is also being explored across other diseases associated with immune system dysregulation, including rheumatoid arthritis, diabetes and cancer.
