Noxopharm aims for clinical trial for first drug in its class

Published: August 19, 2024

Innovative biotech company Noxopharm Limited (ASX:NOX) is pleased to announce its first-in-human study for SOF-SKN™, a novel drug candidate for autoimmune diseases.

The study is scheduled to begin in early calendar year 2025 and will provide proof of concept for the skin disease caused by cutaneous lupus erythematosus (CLE).

The first human experiment will be called HERACLES (for 'Hattractive Eendogen RController Aagainst CLE Study) and will take place in Australia to leverage Australian expertise in lupus research and early-stage clinical trials. Conducting the study in Australia will also help the Company maximize rebates from the Australian Government's R&D Tax Incentive Program.

Noxopharm views the development of SOF-SKN as merely a first step in leveraging the enormous breadth of the Sofra™ platform to address the much larger autoimmune disease market in areas such as rheumatoid arthritis.

As noted in the June 2024 quarterly update, Noxopharm's Sofra™ technology platform is attracting international attention in the industry, which is why several material transfer agreements with mid-sized to multi-billion dollar companies are already in place.

SOF-SKN is a first-in-class oligonucleotide TLR7/8 antagonist that has the potential to change the treatment paradigm of CLE from merely controlling symptoms to actually treating the disease itself at the source.

This first trial will take a phased and cost-effective approach to HERACLES. It is a high-potential, low-risk study with a focus on safety and dose-finding in healthy volunteers.

The study itself will consist of two parts: the first part will be sequential, with participants receiving a single dose of the drug, followed by a safety check. Then, a separate group of participants will receive a higher dose, followed by a safety check. This process will then continue until the maximum dose approved by the ethics committee is reached. The second part will involve several groups of volunteers, also sequential, with each group receiving multiple doses and appropriate safety checks being carried out at each stage.

The study is designed to be simple to conduct and will progress rapidly. Initial safety data are expected to be available four to six weeks after dosing is completed, while a full data analysis should be completed in the fourth quarter of calendar year 2025.

As an essential part of the preparations and following the recent scale-up of production to international quality standards, Noxopharm is currently working on various technical studies to finalise the specific type of SOF-SKN formulation to be used in the HERACLES study.

The company is also in the process of selecting a Phase 1 trial unit and completing numerous other activities required to prepare for a trial in a highly regulated clinical setting, including developing a detailed study protocol, preparing a dossier for submission to the ethics committee, developing an investigator brochure and building the trial database.

Importantly, while the HERACLES trial is ongoing, the Company plans to seamlessly transition to a follow-on trial to treat lupus patients at a number of specialist centres in Australia.

Noxopharm CEO Dr. Gisela Mautner said: “With this study, Noxopharm returns to the small group of ASX-listed Australian companies that have made it to the clinical trial phase. It is an important milestone that we have achieved in record time and we are very pleased to be returning to the clinic with our first product from the promising Sofra platform.

“We have been methodical and thorough and will continue to follow established and approved procedures for conducting clinical trials as we enter this important phase of drug development. Although there is still much work ahead, we are moving development forward as quickly as possible and adhering to the strategy we have developed over the past 18 months.

“Overall, we see this as just the first chapter in the development of the Sofra platform for larger markets. We will make decisions with these ambitions in mind, while continuing to showcase the platform's enormous potential to external stakeholders.”

Autoimmune diseases are diseases in which the body mistakenly attacks itself, and lupus is

just one of many such diseases that affect millions of people worldwide. It is estimated that 14 to 24 million people in the US alone suffer from autoimmune diseases. The global immunology market is expected to grow from USD 92 billion in 2021 to USD 158 billion in 2028.

There are very few treatment options for lupus. Although corticosteroids and corticosteroid-like drugs and antimalarial drugs are commonly prescribed, they only treat the symptoms of the disease and do not affect the disease itself.

Lupus is most commonly diagnosed in young adults between the ages of 15 and 45. There is currently no cure for cutaneous lupus. Treatment of symptoms is usually required on an ongoing or repeated basis, often for life, representing a significant commercial opportunity for any effective drug.

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