Wednesday, Vivani Medical Inc VANI released preclinical data on weight loss effects for NPM-115, the company’s miniature, twice-yearly exenatide subdermal implant under development for chronic weight management.
In a study in high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration.
The company says the weight loss is comparable to that observed in mice treated with Novo Nordisk A/S’s NVO popular Ozempic/Wegovy injections (semaglutide) in the same study.
The supratherapeutic doses provided for both NPM-115 (single administration delivering exenatide at ~530 nmol/kg/day) and semaglutide (weekly injections of ~2,700 nmol/kg/week) were selected to maximize the weight-loss potential of both exenatide and semaglutide.
In a second study in healthy rats, a single administration of exenatide implant NPM-119, in development for type 2 diabetes, resulted in body weights that were approximately 25% lower than a vehicle implant control after 15 weeks of treatment with an expected duration of effect of six months.
NPM-119 delivered exenatide at a rate of approximately 320 nmol/kg/day and has demonstrated smooth, non-fluctuating release of exenatide in both in vitro and in vivo studies.
NPM-119 previously demonstrated pharmacokinetic data exhibiting continuous and therapeutic exenatide exposure levels over six months in healthy rats.
Since NPM-115 is a higher-dose version of an otherwise similar product as NPM-119, the durability of the effect on weight demonstrated in this study is expected to translate to future studies utilizing NPM-115.
The company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration.
These developments are part of a strategic shift to prioritize the company’s obesity implants.
The weight loss potential of exenatide in humans has not been fully evaluated in the currently marketed exenatide products, AstraZeneca Plc’s AZN Byetta (twice-daily injection) and Bydureon (weekly injection) for type 2 diabetes, potentially due to limitations associated with adherence and dosing.
Price Action: VANI shares are trading higher by 1.98% at $1.03 premarket on the last check Wednesday.
Photo by Vidmir Rais via Pixabay
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