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Noxopharm prepares first-in-human trial for SOF-SKN™ [Video]

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Noxopharm prepares first-in-human trial for SOF-SKN™

Noxopharm Ltd (ASX:NOX, OTC:NOXOF) CEO Dr Gisela Mautner joins Proactive’s Tylah Tully to discuss an upcoming first-in-human Phase 1 clinical trial for its SOF-SKN™ drug candidate for cutaneous lupus erythematosus (CLE) treatment.
The trial, named HERACLES, will take place in Australia, leveraging local expertise and potentially R&D tax incentives. This study aims to demonstrate proof of concept for SOF-SKN™, a first-in-class oligonucleotide TLR7/8 antagonist, which could potentially shift CLE treatment from symptom management to addressing the disease at its source.
The trial will begin in early 2025, involving two parts – single-dose and multiple-dose phases with safety checks at each stage. It is expected to last four to six weeks, with comprehensive data analysis planned for the fourth quarter of 2025. Noxopharm intends to follow this trial with another targeting lupus patients at specialist centres in Australia.
This trial represents a significant milestone for Noxopharm, marking the company’s return to clinical trials and the advancement of its Sofra™ platform. The global autoimmune disease market, valued at US$92 billion in 2021, is anticipated to reach US$158 billion by 2028.
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