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Noxopharm Ltd (ASX:NOX) has got its HERACLES trials out the gates in Week 29, dosing a preliminary patient in the first-in-human use of its SOF-SKN topical drug candidate targeting TLR7/8 for autoimmune diseases.
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The biotech company’s early trial focus revolves around cutaneous lupus erythematosus (CLE) and will see SOF-SKN tested through four ascending dose cohorts.
These Australian trials mark a major milestone for Noxopharm as it looks to develop new treatments for autoimmune and inflammatory conditions. It’s essential, the company wrote, to ensure trial data will be accepted.
“To our knowledge, this is the first time a molecule that blocks TLR7/8 in a targeted manner has been used topically in humans, which makes it even more exciting,” said Noxopharm CEO Dr Gisela Mautner as testing got underway.
There’s the financial benefits to consider, too, Dr Mautner added. “The global lupus market is worth more than US$3 billion and is expected to grow significantly.”
The first part of Noxopharm’s trials will be run across four cohorts, each with four participants. The testing schedule will see doses increased from one cohort to the next.
Noxopharm has started the first cohort with the lowest SOF-SKN dose. Once results have come in, the company’s safety steering committee will evaluate the data and decide whether to proceed to the next dose hike.
Should these CLE tests go smoothly, Noxopharm will move on to testing around other autoimmune-related skin diseases like psoriasis and atopic dermatitis.
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Dr Mautner also suggested that the core Sofra technology in Noxopharm’s doses could eventually be utilised for rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease, and diseases linked to immune system dysregulation.
NOX has climbed +12.5% to lunchtime trade, to sell at 5.4cps.
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