Noxopharm (ASX:NOX) has announced its first-in-human trial for SOF-SKN, a novel investigative candidate for autoimmune diseases.
The company said it plans to start the trial in early 2025 and provide proof of concept for the skin disease caused by cutaneous lupus erythematosus (CLE).
Lupus is one of a wide range of autoimmune diseases that affect millions of people worldwide. There are limited treatment options available for people living with lupus. It is most often diagnosed in young adults aged 15 to 45. 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.
The trial, known as HERACLES (Harnessing Endogenous Regulators Against CLE Study), will take place at sites in Australia.
Noxopharm is developing SOF-SKN using its Sofra platform, which is focused on supporting the development of a novel class of immunomodulators. SOF-SKN is a first-in-class oligonucleotide TLR7/8 antagonist that can potentially change the treatment paradigm of CLE from merely controlling symptoms to treating the disease itself right at the source.
HERACLES will be a high-potential, low-risk study with two parts that focus on safety and dose finding in healthy volunteers.
The first will proceed sequentially and involve participants receiving a single dose of the drug, followed by a safety check, and then a separate cohort of participants receiving a higher dose, followed by a safety check. This process will continue until the maximum dose has been reached, as approved by the ethics committee.
The second part will involve several groups of volunteers, again sequentially, each receiving multiple doses with appropriate safety checks at each stage.
The first safety readouts are expected to be available four to six weeks after dosing, and a comprehensive data analysis should be completed in the fourth quarter of 2025.
Noxopharm said it is now finalising the specific type of SOF-SKN formulation to be used in the HERACLES trial via various technical studies.
CEO Dr Gisela Mautner said, “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. 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.”