Highlights:

NOX begins dosing in first-in-human HERACLES trial evaluating SOF-SKN for autoimmune diseases.

Noxopharm tests four escalating doses of SOF-SKN™ in Australian cutaneous lupus study.

NOX conducts trial locally to access R&D incentives and leverage autoimmune research expertise.

Noxopharm Limited (ASX:NOX), a clinical-stage biotechnology company, has initiated dosing in its first-in-human HERACLES clinical trial, marking the initial human application of SOF-SKN™, a topical drug candidate designed to address autoimmune diseases. The trial represents the first clinical step for the company’s proprietary Sofra™ drug platform.

HERACLES is being conducted in Australia and focuses initially on cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. The purpose of the study is to assess the safety and tolerability of SOF-SKN™ across four ascending dose levels. The trial includes four cohorts of four participants each, starting with the lowest dose. After the initial cohort completes dosing, a safety steering committee will evaluate the data to decide whether to proceed with higher dose levels in subsequent cohorts.

Australia was selected as the trial location not only for its research in lupus and early-phase clinical trials, but also because local execution of the study qualifies Noxopharm for Australian federal R&D tax rebates.

The lead-up to first dosing involved extensive preparation. Since receiving ethics approval, multiple teams coordinated efforts across several functions. These included the manufacture, labelling, and shipment of the SOF-SKN compound, site-specific clinical setup, trial database development and testing, and participant recruitment. This background work ensures compliance with regulatory standards, which is essential for data acceptance by both Australian and international authorities.

SOF-SKN™ is a topical formulation developed to selectively inhibit Toll-like receptors 7 and 8 (TLR7/8) pathways known to play a central role in triggering inflammation in autoimmune conditions. According to Noxopharm, this is the first instance of a molecule targeting TLR7/8 being applied topically in humans.

Noxopharm’s Chief Executive Officer, Dr Gisela Mautner, acknowledged the significance of the milestone, noting that the trial brings the Sofra™ platform into clinical use. Dr Mautner also stated that the global market for lupus treatments is currently valued at over AUD 3 billion, with projections of further expansion.

Following the initial CLE focus, Noxopharm intends to explore additional dermatological applications of SOF-SKN™, including psoriasis and atopic dermatitis, both of which are also associated with immune system dysregulation. The broader Sofra™ drug platform may potentially be adapted for other autoimmune and inflammatory diseases such as rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and even neurological conditions such as dementia, where immune pathways may play a contributory role.

HERACLES is structured to provide a phased evaluation of SOF-SKN's tolerability before any efficacy assessments are pursued in later-stage trials. Regulatory feedback from this initial study is expected to shape the design of future clinical development programs targeting a wider range of autoimmune disorders.

NOX trading at 45.83 % higher at AUD 0.070 per share as on 16 July 2025.