Noxopharm (ASX:NOX) Announces Start of Daily Dosing in HERACLES SOF-SKN™ Trial

Noxopharm Limited (ASX:NOX) has initiated the Noxopharm HERACLES Trial Daily Dosing in Part Two of its study, a key step in the evaluation of SOF-SKN™ for autoimmune treatment. This clinical-stage biotechnology company is now positioned to generate important safety and tolerability data for its novel topical treatment targeting cutaneous lupus erythematosus, an ailment with a global market estimated at over US$3.3 billion.

The HERACLES trial represents Noxopharm’s first-in-human evaluation of SOF-SKN™, utilising the company’s proprietary Sofra™ technology platform to develop treatments for inflammatory and autoimmune diseases. This ASX announcement signals the progression from single-dose testing to repeated daily applications over two weeks, closely reflecting real-world treatment conditions for chronic autoimmune patients.

Furthermore, the trial’s strategic location in Australia enables Noxopharm to capitalise on local expertise in lupus research and early-phase clinical trials whilst securing federal R&D tax benefits. This investor update highlights the company’s commitment to cost-efficient development within a highly competitive biotechnology landscape.

What Sets the Noxopharm HERACLES Trial Daily Dosing Protocol Apart?

The HERACLES trial Part Two employs a sophisticated dose-escalation protocol designed to evaluate SOF-SKN autoimmune treatment under intensive conditions. This approach represents a significant evolution from earlier single-dose studies, incorporating multiple safety assessments and pharmacological evaluations to mirror actual patient usage patterns.

The trial design incorporates two sequential cohorts with four participants each, receiving daily dosing for 14 consecutive days per cohort. This extended exposure period enables researchers to observe safety patterns that might not emerge during single-dose administration, addressing a critical gap in preliminary safety data.

Key Trial Specifications:

• Two sequential cohorts with four participants each
• Daily dosing for 14 consecutive days per cohort
• Dose escalation protocol with Safety Steering Committee oversight
• Detailed safety monitoring through multiple assessment methods
• Battery of tests including electrocardiograms and blood work
• Skin observation scoring at multiple timepoints
• Participant questionnaires for tolerability assessment

The trial design incorporates electrocardiograms, physical examinations, blood tests, skin observation scoring, and participant questionnaires administered at multiple timepoints. This extensive evaluation framework ensures thorough data collection for regulatory submissions whilst maintaining participant safety as the primary objective.

Dr Gisela Mautner, CEO and Managing Director, stated: “The momentum we have built up over recent months is now continuing, and we are very pleased that dosing has begun on a daily basis. This second part of the trial will produce more data that will strengthen our data package and enhance our position in regard to the upcoming regulatory approval process.”

The repeated administrations plus subsequent readouts will take several weeks for each cohort due to the thorough testing protocol. However, this detailed approach strengthens the overall data package that will support future regulatory submissions and commercial discussions.

How Does the Daily Dosing Schedule Reflect Real-World Treatment Conditions?

The Noxopharm HERACLES Trial Daily Dosing protocol specifically addresses a critical aspect of autoimmune disease management: the need for ongoing, repeated treatment. Cutaneous lupus erythematosus presents as an incurable chronic disease, requiring continuous therapy to manage symptoms effectively over extended periods.

This approach enables safety testing to continue at a more intensive level over a longer period, more closely reflecting how topical treatments of this type are commonly used in real-world situations. Patients with chronic autoimmune conditions would potentially need to use SOF-SKN on an ongoing basis to help relieve their symptoms, making extended exposure data essential for regulatory approval.

Real-World Relevance:

• Extended daily application mimics actual patient usage patterns
• Chronic disease management requires ongoing treatment protocols
• Topical formulations typically require repeated applications
• Long-term safety data supports physician prescribing confidence
• Tolerability over time directly impacts patient compliance

The double-blind and placebo-controlled Phase I trial aims to evaluate the safety and tolerability profile of SOF-SKN by testing it at different concentrations. This methodological rigour ensures that any observed effects can be confidently attributed to the active treatment rather than placebo responses or external factors.

In addition, the dose escalation approach allows researchers to identify the optimal concentration that balances efficacy with safety. The first cohort receives a lower dose, followed by a Safety Steering Committee meeting before the second cohort is scheduled to receive a higher dose, ensuring participant welfare remains paramount throughout the study.

What Is the Mechanism of SOF-SKN Technology for Autoimmune Diseases?

SOF-SKN™ utilises Noxopharm’s proprietary Sofra™ technology, which comprises short nucleic acid sequences called oligonucleotides that target specific immune sensors to regulate inflammation at its source. This mechanism represents a fundamental departure from traditional immunosuppressive approaches that broadly dampen immune function.

The proprietary platform is based on oligonucleotides that act on specific immune sensors to regulate inflammation, reducing or stimulating it to control the disease. In essence, the Sofra technology for autoimmune diseases aims to replicate what is naturally occurring in the bodies of healthy people but is either absent or deficient in patients with autoimmune conditions.

Mechanism of Action:

• Targets inflammatory pathways absent or deficient in autoimmune patients
• Replicates natural immune regulation found in healthy individuals
• Provides topical delivery for direct skin application
• Designed for ongoing use in chronic, incurable conditions
• Avoids broad immunosuppression associated with systemic therapies
• Potentially reduces systemic side effects through localised treatment

The Sofra technology platform offers potential applications in a wide range of diseases related to the immune system such as rheumatoid arthritis, lupus and diabetes, as well as other diseases like cancer. This versatility positions Noxopharm to address multiple disease areas within the expanding autoimmune therapeutics market.

SOF-SKN is initially being developed for autoimmune diseases like cutaneous lupus erythematosus before potential development for autoimmune-related skin diseases like psoriasis and dermatomyositis. This staged development approach enables the company to establish proof-of-concept in one indication before expanding into adjacent therapeutic areas.

What Market Opportunity Does This Noxopharm Clinical Trial Advancement Present?

The progression to daily dosing in the HERACLES trial positions Noxopharm clinical trial advancement within substantial market opportunities across multiple therapeutic areas. The global autoimmune disease therapeutics market was valued at US$163.2 billion in 2024 and is expected to reach US$219.6 billion by 2035, representing significant commercial potential.

The global cutaneous lupus erythematosus market is worth more than US$3.3 billion and is expected to grow significantly over the coming years. This represents Noxopharm’s initial target indication, offering a substantial addressable market with significant unmet medical needs.

Market Size Analysis:

The worldwide immuno-oncology market was US$43 billion in 2023 and is projected to hit US$284 billion by 2033. This represents additional commercial opportunities for Noxopharm’s technology platform beyond autoimmune indications, diversifying potential revenue streams.

The cutaneous lupus market represents a significant opportunity for SOF-SKN, particularly given the limited effective treatment options currently available. The topical delivery method could provide competitive advantages through improved tolerability profiles compared to systemic alternatives that carry broader side effect risks.

Moreover, the Sofra technology platform offers pipeline expansion potential across multiple indications, creating diversified revenue opportunities that reduce single-asset development risk whilst maximising commercial potential. This strategic positioning enhances the company’s attractiveness to potential pharmaceutical partners and investors.

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