Noxopharm Ltd (ASX:NOX, OTC:NOXOF) is preparing to launch a first-in-human Phase 1 trial assessing SOF-SKN™ drug candidate and Sofra™ platform for autoimmune diseases in its HERACLES or ‘Harnessing Endogenous Regulators Against CLE Study’.
NOX sees the Australia-based trial as the first step in leveraging the Sofra™ platform’s potential to tackle the autoimmune disease market in areas such as rheumatoid arthritis.
Holding the trials within Australia will offer access to R&D tax incentives from the Federal Government and Australian expertise in lupus research and early-phase clinical trials.
The trial is planned to start in early 2025 and is designed to provide proof of concept for the skin disease that is 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 right at the source.
Advancing Sofra across large markets
“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,” Noxopharm CEO Dr Gisela Mautner said.
“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.
“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.”
NOX’s Sofra™ platform is a novel class of immunomodulators capable of improving mRNA vaccines and mRNA therapeutics as well as treating autoimmune diseases.
Sofra’s most advanced preclinical asset, SOF-VAC™, has potential applications in the treatment of excessive inflammatory responses associated with specialised inflammatory receptors in the body known as Toll-like receptor 7, or TLR 7 and the company is also targeting TLR 8 and cGAS receptors.
HERACLES trial
NOX has designed HERACLES as an incremental and cost-effective study format, described as a high-potential, low-risk study focusing on safety and dose finding in healthy volunteers.
The trial will be conducted over two parts, the first being a sequential timetable of single doses, followed by a safety check, then a separate cohort of participants receiving a higher dose, followed by a safety check.
Part one will continue until the maximum dose as approved by the ethics committee has been reached. Part two will involve several groups of volunteers each receiving multiple sequential doses with appropriate safety checks at each stage.
With a focus on speed, Noxopharm expects the trial itself to take four to six weeks to complete and a comprehensive data analysis in the fourth quarter of calendar year 2025.
Importantly, while the HERACLES trial is ongoing, NOX intends to action a seamless transition to a follow-on trial targeting the treatment of lupus patients at a number of specialist centres in Australia.
Currently, there is no cure for skin lupus. Treatment of the symptoms is usually required on an ongoing or recurring basis, often for life, representing a significant commercial opportunity for any effective medication.
Lupus is one of just a wide range of autoimmune disease. In the US alone there are between 14 and 24 million people suffering from autoimmune diseases, with the global market valued at US$92 billion in 2021 and expected to grow to US$158 billion in 2028.