Noxopharm aims for autoimmune market with first human trial of SOF-SKN

Biotech company Noxopharm Ltd (ASX:NOX) has announced that the first human trial testing SOF-SKN – a novel drug designed to treat autoimmune diseases such as lupus – will begin in Australia next year, leveraging rebates from the federal government’s R&D Tax Incentive scheme.

The trial will begin in early 2025 and focus particularly on proving the concept of the skin disease that is caused by cutaneous lupus erythematosus (CLE), with this being reflected in the study’s name: HERACLES (or ‘Harnessing Endogenous Regulators Against CLE Study’).

The drug SOF-SKN is a first-in-class oligonucleotide TLR7/8 antagonist which is designed around not only controlling CLE symptoms but treating them at the source.

With expectations of early results from the trial, Noxopharm anticipates that it will provide a pipeline for the company’s Sofra platform of drugs (those that treat inflammation, autoimmunity, and mRNA vaccine enhancement) to become marketable for the treatment of other autoimmune diseases such as rheumatoid arthritis.

CEO Dr Gisela Mautner said the trial’s announcement represented an important stage in Noxopharm’s development.

“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,” she said.

“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 of 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.

“At the big picture level, we very much see this as just the first chapter in developing the
Sofra platform across larger markets.”

The amrekt seemed enthused by the news, and at 11:25 AEST, Noxopharm shares were trading at 8.8 cents, a rise of 7.32% since the market opened.