Australian biotech company Noxopharm has announced the initiation of the first-in-human clinical trial of its drug candidate, SOF-SKN, targeting the treatment of autoimmune diseases, specifically cutaneous lupus erythematosus (CLE).

Dubbed ‘Harnessing Endogenous Regulators Against CLE Study’ (HERACLES), the trial is scheduled to begin early next year and aims to provide proof of concept for this innovative approach to treating CLE.

HERACLES will leverage Australian expertise in lupus research and early-phase clinical trials, with the added benefit of maximising rebates from the Australian Government’s R&D Tax Incentive scheme.

An oligonucleotide TLR7/8 antagonist, SOF-SKN is claimed to have the potential to shift the CLE treatment paradigm from symptom control to addressing the disease at its source.

The HERACLES study will adopt a cost-efficient, incremental approach, prioritising safety and dose finding in healthy subjects.

It will be divided into two parts: the first involves sequential single-dose administration with safety checks, and the second consists of multiple doses across several volunteer groups, with safety assessments at each stage.

The initial safety results from the HERACLES trial are anticipated within four to six weeks post-dosing, with a full data analysis expected in the fourth quarter of next year.

As part of the trial preparations, Noxopharm is finalising the specific SOF-SKN formulation through technical studies following the recent scale-up of production to international quality standards.

In addition, the company is selecting a Phase I trial unit and undertaking other necessary preparations for a trial in a heavily regulated clinical environment.

These preparations include designing a detailed trial protocol, preparing an ethics submission dossier, developing an Investigator’s Brochure, and constructing the trial database.

Concurrently, the company is planning a seamless transition to a subsequent trial aimed at treating lupus patients at specialist centres across Australia.

Noxopharm CEO Dr Gisela Mautner said: “This trial marks the return of Noxopharm to the small group of ASX-listed Australian companies that have made it to the clinical trial stage. It is a major milestone that we have achieved in record time, and we are really pleased to be going back to the clinic with our first asset from the very promising Sofra platform.

“We have been methodical and thorough in our approach, and we will continue to comply with established and approved procedures for conducting clinical trials as we begin this important phase of the drug development journey. While there is still a lot of work ahead, we are pressing forward as rapidly as possible and in line with the strategy we have set out over the past 18 months.”