Peptron has filed an investigational new drug application for PT403, a once-monthly semaglutide injection designed to improve obesity treatment adherence, marking a significant step in its development using the SmartDepot sustained-release technology.
Peptron has moved a step closer to testing its once-monthly semaglutide injection PT403 after filing an investigational new drug application with South Korea’s Ministry of Food and Drug Safety, according to Etoday. The company says the experimental treatment uses its SmartDepot sustained-release platform and is intended to extend semaglutide’s dosing interval from once a week to once a month.
The first-stage trial is set to enrol 22 healthy adults at the Clinical Trial Centre of Chungnam National University Hospital. According to reports by Chosun Biz and Edaily, the study will assess safety, tolerability and pharmacokinetic behaviour after a single subcutaneous dose, with patients split into three cohorts and later dose increases to proceed only after a safety review.
Peptron is developing PT403 around semaglutide, the active ingredient in Novo Nordisk’s Wegovy, as part of a broader effort to compete in the fast-growing obesity treatment market through convenience as well as efficacy. The company says the aim is to offer a longer-acting option that could improve treatment adherence if later-stage trials are successful.
The filing follows preclinical and early human data presented by Peptron at the American Diabetes Association meeting in June. According to the company’s presentation, PT403 produced sustained weight reduction in an obesity mouse model, while a pilot study in healthy adults suggested a favourable safety and tolerability profile, with fewer adverse events than a standard weekly semaglutide regimen and no serious adverse events reported.
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