Aussie biotech to initiate early phase trial in autoimmune disease

Biotech News: Australian biotech company Noxopharm is gearing up to embark on its first in-human trial of SOF-SKN, a drug candidate aimed at combating cutaneous lupus erythematosus (CLE), a challenging skin condition linked to the autoimmune disease lupus.

Scheduled for early 2025, the HERACLES (Harnessing Endogenous Regulators Against CLE Study) trial will unfold on home turf in Australia, strategically leveraging local expertise in lupus research and early-phase clinical trials. This decision also positions Noxopharm to maximise benefits from the R&D Tax Incentive scheme.

SOF-SKN represents a pioneering oligonucleotide TLR7/8 antagonist, potentially changing the treatment paradigm of CLE by targeting the disease at its core rather than merely managing symptoms.

Noxopharm CEO, Dr Gisela Mautner, emphasised the significance of this milestone, stating, “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 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.”

Anticipated safety readouts from the trial are expected to be available four to six weeks after dosing concludes, with comprehensive data analysis slated for late 2025.

Looking beyond CLE, Noxopharm views SOF-SKN as an initial stride in harnessing its Sofra platform’s vast potential across broader autoimmune disease landscapes, including rheumatoid arthritis. The platform’s appeal has already attracted international interest, resulting in strategic agreements with mid-sized to billion-dollar companies.

“At the big picture level, we very much see this as just the first chapter in developing the Sofra platform across larger markets. We will make decisions with these ambitions in mind while continuing to introduce the huge potential of the platform to external stakeholders,” Dr Mautner remarked.

The urgency for effective lupus treatments is stark; current options focus on symptom management without addressing the underlying disease. With lupus primarily afflicting young adults aged 15 to 45, and no cure available for skin lupus, ongoing symptomatic treatment poses a perpetual necessity, presenting a substantial commercial opportunity for innovative medicines.

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