Noxopharm Completes HERACLES Clinical Trial with Strong Safety Results for SOF-SKN

Noxopharm (ASX: NOX) has announced the successful completion of its HERACLES clinical trial, with the second and final multiple dose cohort now finalised and no clinically relevant safety issues observed across any dosing groups.

The trial assessed SOF-SKN, a topical drug developed for inflammatory and autoimmune skin conditions. According to the company, the Safety Steering Committee concluded the treatment was safe and well tolerated, paving the way for Phase II-enabling studies and future scale-up of drug production.

Noxopharm CEO Dr Gisela Mautner said the primary aim of the trial was to assess the safety of SOF-SKN across multiple applications and dosages. “We have passed both aspects with flying colours,” she said. “We now move on to preparing for our next goal, which is to test SOF-SKN on lupus patients”.

The HERACLES trial covered both single-dose and multiple-dose cohorts and progressed rapidly from recruitment to completion. High compliance was reported among participants throughout the study.

SOF-SKN is being developed initially to treat cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. The global market for CLE is currently estimated at over US 3.3 billion and is expected to grow in coming years. Beyond CLE, the company sees commercial potential for SOF-SKN in other autoimmune skin diseases such as psoriasis and dermatomyositis.

SOF-SKN is based on Noxopharm’s Sofra platform, a nucleic acid-based technology designed to regulate immune response at its source. The same platform is being investigated for applications in rheumatoid arthritis, diabetes, and other immune-related conditions.

The announcement marks a significant milestone in Noxopharm’s clinical development program and positions the company to advance SOF-SKN into Phase II trials, with a focus on efficacy testing in patients with lupus.