Noxopharm (ASX:NOX) Announces Commencement of Multi-Dose Testing in HERACLES Trial

Clinical-stage biotechnology company Noxopharm Limited (ASX:NOX) has reached a significant milestone in the Noxopharm HERACLES clinical trial, initiating multi-dose testing for its SOF-SKN drug candidate. This topical treatment is being developed for autoimmune diseases, initially targeting the global cutaneous lupus market, which is valued at over US$3.3 billion. As an investor update, this progression follows the successful completion of single-dose safety testing. Noxopharm has a market capitalisation of [Insert Market Cap] with [Insert Shares on Issue] shares on issue and a reported cash position of $1.545 million.

Following excellent safety results in the initial phase, the trial’s Safety Steering Committee authorised the advancement, permitting the trial to bypass the two lowest dose cohorts. This decision is expected to accelerate development timelines and represents confidence in the SOF-SKN safety profile, creating a more efficient pathway towards regulatory review while maintaining rigorous safety standards.

What Does Multi-Dose Testing Mean for the Noxopharm HERACLES Clinical Trial?

The Noxopharm HERACLES clinical trial has now moved into its second phase after demonstrating a positive safety profile in single-dose applications on healthy volunteers. This first-in-human trial for the SOF-SKN drug candidate serves to validate Noxopharm’s proprietary Sofra technology platform, which has potential applications across multiple autoimmune conditions.

The trial’s progression, bypassing the lowest dose cohorts, reduces development costs and allows resources to be focused on clinically relevant dose ranges. This approach establishes an efficient pathway for this novel autoimmune disease therapeutic.

Key trial parameters include:

• Two cohorts of four participants each
• Daily application for 14 days per cohort
• Approximately one month in duration per cohort
• Conducted in Melbourne in partnership with Doherty Clinical Trials
• Detailed safety assessments, including electrocardiograms, blood tests, and skin observation scoring

The intensive testing schedule is designed to mirror real-world treatment conditions for patients with cutaneous lupus erythematosus (CLE), a chronic condition requiring ongoing medication. This relevance strengthens the clinical development pathway and regulatory positioning.

What is the SOF-SKN Mechanism of Action for Cutaneous Lupus?

SOF-SKN is based on Noxopharm’s Sofra technology platform, which uses short nucleic acid sequences, known as oligonucleotides, to target specific immune sensors and regulate inflammation. The topical cream is designed to replicate natural immune regulation that may be absent or insufficient in patients with autoimmune conditions. This method offers a new approach to developing a cutaneous lupus treatment.

The global market for autoimmune disease therapeutics provides substantial context for this development.

The Sofra platform’s potential extends beyond cutaneous lupus to other conditions such as psoriasis, dermatomyositis, and rheumatoid arthritis, creating multiple opportunities from a single technology foundation.

What are the Benefits of the Accelerated Trial Timeline?

The decision to skip the two lowest dose cohorts in the Noxopharm HERACLES clinical trial was based on the excellent safety profile shown in single-dose testing. This advancement offers several benefits for the development programme.

Acceleration benefits include:

• Reduced Timeline: Faster progression to therapeutically relevant doses.
• Cost Efficiency: Lower development expenses due to streamlined testing.
• Regulatory Confidence: Strong safety data supports future regulatory discussions.

Dr Gisela Mautner, CEO of Noxopharm, stated: “Now that we have successfully applied SOF-SKN in single doses to healthy volunteers, we are ramping up the testing to ensure it is safe across repeated doses. This is a vital aspect of the drug development process as regulatory authorities have strict safety approval processes for when and how new drugs are allowed to be given to people.”

The safety monitoring protocol includes electrocardiograms, physical examinations, blood tests, and skin observation scoring to ensure participant safety and generate robust data for regulatory submissions.

When are Noxopharm HERACLES Trial Results Expected?

The multi-dose testing phase offers clear visibility on upcoming milestones for investors. Participant recruitment is currently ongoing, with the first cohort scheduled to receive initial doses once recruitment is complete.

Timeline and milestones:

• Current Status: Participant recruitment is underway.
• Cohort Duration: Approximately one month per cohort.
• Data Collection: Safety assessments will be performed at multiple timepoints.
• Safety Review: The committee will review data following each cohort’s completion.
• Expected Duration: The multi-dose phase is anticipated to take 2-3 months from commencement.

Each cohort’s data will be evaluated by the Safety Steering Committee before progression to a higher dose is authorised. Investors can expect updates as each cohort completes testing, providing validation points for SOF-SKN’s safety profile.

Why is the HERACLES Trial Being Conducted in Australia?

Noxopharm is conducting the Noxopharm HERACLES clinical trial in Australia to leverage several key advantages. The company benefits from federal R&D tax incentives while accessing local expertise in lupus research and early-phase clinical trials.

Advantages of an Australian trial include:

• Cost Efficiency: Australian R&D tax incentives reduce development expenses.
• Clinical Expertise: Access to world-class lupus research capabilities.
• Regulatory Environment: Established pathways for early-phase clinical development.
• Partnership Network: Collaboration with experienced organisations like Doherty Clinical Trials.

Australia’s reputation for high-quality clinical research adds credibility to the data generated, which is valuable for future regulatory submissions and potential partnership discussions.

What is the Market Potential of the Sofra Platform?

The Sofra technology platform provides a differentiated approach to immune system regulation. Its applications extend beyond the initial cutaneous lupus indication, creating multiple value drivers for investors.

Platform applications include:

• Primary Indication: Cutaneous lupus erythematosus (CLE).
• Autoimmune Diseases: Potential use in psoriasis, dermatomyositis, and rheumatoid arthritis.
• Metabolic Conditions: Applications in conditions such as diabetes.
• RNA Therapeutics: Potential to enhance the safety profiles of mRNA medicines.
• Oncology: Applications in immune system modulation for cancer treatment.

The technology’s foundation in oligonucleotides enables precise inflammation control at its source, which is a key differentiator from broader immunosuppressant therapies. This ASX announcement confirms the company is advancing a platform with considerable potential across the high-value therapeutics market.

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