Clinical-stage company Noxopharm (ASX:NOX) has reported new data that strengthens the case for a future human trial of its cutaneous lupus drug candidate, SOF SKN, following the recent successful completion of its Phase 1 HERACLES safety study.
The company has been examining in greater detail how often the treatment may need to be administered, with a focus on identifying an optimal dosing regimen as it prepares the next stage of clinical development and regulatory engagement.
Using an in vivo animal model, researchers evaluated the uptake of SOF 16, the active ingredient in SOF SKN, at the highest dose tested in the HERACLES trial across both normal and disease-like skin. The pharmacokinetic work was designed to determine how to maintain consistent and therapeutically relevant drug levels in the skin over defined periods. It also assessed how much of the drug remains localised in the skin compared to any absorption into the bloodstream, reflecting the formulation’s intent to avoid systemic exposure.
The findings confirmed several favourable characteristics. In both normal and disease-like skin, SOF 16 demonstrated a half-life of approximately 3.5 days. This extended persistence in the target tissue, combined with the safety profile observed to date, suggests the potential for sustained therapeutic activity after each dose. It also opens the possibility of dosing less frequently than once daily, which could improve convenience and support adherence in chronic treatment settings.
Further analysis showed that the drug remained almost entirely within the epidermis and dermis, the layers where it is intended to act. Absorption into the bloodstream was below the limit of quantification at all measured time points. This localised exposure profile supports the goal of suppressing innate immune activation within the skin while minimising the risk of broader systemic immunosuppression.
Following these results, the company has moved to engage a contract research organisation to support preparations for a human trial. Chief executive Olivier Laczka said, “These results take us a step further in SOF SKN’s development and show that the drug is going where we want it to be going in the body, even in the setting of diseased skin. We strongly believe our SOF SKN approach could provide a solution to millions of people suffering from chronic inflammatory skin conditions, and we will press ahead as we compile our data package in preparation for a trial and regulatory submissions.”
SOF SKN is initially being developed to treat the chronic inflammation associated with cutaneous lupus erythematosus, with potential expansion into other autoimmune-related skin diseases such as psoriasis and dermatomyositis.