Noxopharm starts first human clinical trial for Proactive Investors’ autoimmune disease SOF-SKN™

Noxopharm Ltd (ASX:NOX, OTC:NOXOF) is preparing to initiate a first-in-human Phase 1 study to evaluate its drug candidate SOF-SKN™ and Sofra™ platform for autoimmune diseases as part of its Harnessing Endogenous Regulators Against CLE Study (HERACLES).

NOX views the trial conducted in Australia as a first step to fully exploit the potential of the Sofra™ platform and conquer the autoimmune disease market in areas such as rheumatoid arthritis.

Conducting the trials in Australia will provide access to research and development tax incentives from the Australian Federal Government, as well as Australian expertise in lupus research and early-stage clinical trials.

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

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.

Promoting Sofra in major markets

“This study marks Noxopharm’s return to the small group of ASX-listed Australian companies that have made it to the clinical trial phase,” said Dr Gisela Mautner, CEO of Noxopharm.

“This is an important milestone that we have achieved in record time and we are very pleased to return to the clinic with our first product from the extremely promising Sofra platform.

“We have been methodical and diligent in our approach 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 a lot of work ahead of us, we are moving forward as quickly as possible and sticking 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 take these ambitions into account in our decisions while continuing to communicate the platform’s enormous potential to external stakeholders.”

NOX's Sofra™ platform is a novel class of immunomodulators with the potential to enhance mRNA vaccines and mRNA therapeutics and treat autoimmune diseases.

SOF-VAC™, Sofra's most advanced preclinical compound, can be used to treat excessive inflammatory responses associated with specific inflammatory receptors in the body called Toll-like receptor 7 or TLR 7. In addition, the company is also targeting TLR 8 and cGAS receptors.

HERACLES study

NOX has designed HERACLES as an incremental and cost-effective study format, described as a high potential, low risk study with a focus on safety and dose finding in healthy volunteers.

The study will be conducted in two parts. The first part will consist of a sequential schedule of single doses followed by a safety review. Then a separate cohort of participants will receive a higher dose followed by a safety review.

The first part will continue until the maximum dose approved by the Ethics Committee is reached. In the second part, several groups of volunteers will receive several consecutive doses, with appropriate safety checks carried out at each stage.

Noxopharm is focusing on speed and expects the study itself to take four to six weeks and comprehensive data analysis to take place in the fourth quarter of calendar year 2025.

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

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.

Lupus is one of many autoimmune diseases. In the United States alone, between 14 and 24 million people suffer from autoimmune diseases. The global market is estimated to be worth $92 billion in 2021 and is expected to grow to $158 billion by 2028.

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