Noxopharm’s Skin Drug Shows 3.5 Day Half Life, Clearing Path to Human Trials
Noxopharm reports 3.5-day half-life for SOF-SKN in preclinical skin retention study
Noxopharm has announced positive preclinical data for SOF-SKN, its topical drug candidate for cutaneous lupus erythematosus. The pharmacokinetic study showed SOF-16, the active ingredient in SOF-SKN, demonstrated a half-life of approximately 3.5 days in both normal and disease-like skin.
The study was designed to support dosing regimen decisions ahead of human trial preparations, following the successful conclusion of the Phase 1 HERACLES safety trial. The drug was tested at the highest dose from the HERACLES trial using an in vivo animal model.
The company is now engaging a Contract Research Organisation (CRO) to support preparations for human trials and regulatory submissions.
The positive preclinical data de-risks the pathway to human trials by validating the dosing regimen and drug behaviour before regulatory submission, providing the foundation for advancing SOF-SKN into the next development phase.
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What is SOF-SKN and why does skin retention matter?
SOF-SKN is Noxopharm’s topical drug candidate for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. The drug is formulated to remain in the skin layers, specifically the epidermis and dermis, rather than entering the bloodstream.
This localised retention is desirable because it allows sustained suppression of local immune activation within the skin whilst minimising systemic immunosuppression. By avoiding body-wide side effects, SOF-SKN aims to provide a safer treatment option for chronic autoimmune skin conditions.
The Sofra technology platform underpins SOF-SKN, targeting inflammatory and autoimmune diseases through oligonucleotide-based immune regulation. The platform comprises a novel class of drugs that act on specific immune sensors to regulate inflammation at its source.
Topical drugs that stay localised in target tissue may offer better safety profiles than systemic treatments, a key differentiator in chronic disease management where patients require long-term therapy.
Key findings from the pharmacokinetic study
The study revealed two main findings:
- Half-life of approximately 3.5 days in the dermis across both normal and disease-like skin
- Drug remained almost entirely in the epidermis and dermis with systemic absorption below quantifiable levels at all time points
The longer skin residence time may support sustained therapeutic activity and enable less frequent dosing beyond once daily. This potential dosing advantage could improve patient adherence in chronic treatment settings, where convenience plays a crucial role in long-term compliance.
Dr Olivier Laczka, CEO
“These results take us a step further in SOF-SKN’s development and show that the drug is going where we want it to be going in the body, even in the setting of diseased skin.”
The lack of systemic absorption allows for sustained suppression of local innate immune activation within the skin, with minimal undesirable systemic immunosuppression. This characteristic addresses a key challenge in autoimmune disease treatment where balancing efficacy and safety is critical.
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Market opportunity and development pathway
SOF-SKN is initially being developed for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. The global CLE market is worth more than US$3.3 billion and is expected to grow significantly over the coming years.
Beyond CLE, the drug has potential expansion indications including psoriasis and dermatomyositis. The broader Sofra platform could be utilised for rheumatoid arthritis and diabetes, plus other diseases linked to immune system dysregulation.
The company is now in the process of engaging a CRO to support preparations for a human trial and compile the data package for regulatory submissions.
| Element | Detail |
|---|---|
| Drug Candidate | SOF-SKN (active ingredient: SOF-16) |
| Initial Indication | Cutaneous lupus erythematosus (CLE) |
| CLE Market Size | >US$3.3 billion globally |
| Potential Expansion | Psoriasis, dermatomyositis, rheumatoid arthritis, diabetes |
| Next Milestone | CRO engagement for human trial preparation |
The positive preclinical results in a multi-billion dollar market provide the foundation for regulatory discussions and potential expansion across the broader autoimmune disease space. The global autoimmune disease therapeutics market was worth US$163.2 billion in 2024 and is expected to reach US$219.6 billion by 2035.
What to watch next
Upcoming catalysts that will further de-risk the SOF-SKN development programme include:
- CRO selection and engagement announcement
- Human trial design and regulatory submission progress
- Updates on the broader Sofra platform pipeline
These milestones will provide visibility into the company’s progress towards clinical development and potential commercialisation of SOF-SKN across multiple autoimmune indications.
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