Australian Biotech Company, Naxopharm Limited, Announces its First In-Human Study of Investigational Treatment, SOF-SKN, for Cutaneous Lupus

The Harnessing Endogenous Regulators Against CLE Study (HERACLES) is planned to begin in early 2025 and will serve as a proof-of-concept study for the investigational therapy, SOF-SKN™, for treatment of cutaneous lupus erythematosus disease (CLE), or lupus skin disease. The study is aimed at evaluating safety and determining the optimal dosage in healthy participants. Lupus affects different people in different ways and most people with lupus have skin problems, like rashes or sores. 

In the HERACLES study, researchers will examine the potential of the first-in-class oligonucleotide TLR7/8 antagonist, SOF-SKN, in transforming the treatment approach for CLE, by shifting the focus from symptom management to addressing CLE at its source. The study will be conducted in two parts. Study participants in the first part will receive a single dose of the drug, followed by a safety evaluation. Subsequently, a different group of participants will receive a higher dose of the same therapy, followed by another safety check. This process will continue until the maximum dose approved by the ethics committee is reached. In the second part of the study, several groups of participants will receive multiple doses of the therapy with safety assessments conducted at each stage. 

Drug safety data is expected after 4-6 weeks of initial dosing and comprehensive findings are expected in the fourth quarter of 2025. 

Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about lupus and the skin and treatments being studied for lupus.

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