EXCLUSIVE: Vivani Medical Reveals Positive Preclinical Liver Fat Results From Miniature GLP-1 Implant For Obesity

On Wednesday, Vivani Medical, Inc. VANI reported preclinical liver fat results with its exenatide implant for obese patients.

Exenatide is sold by AstraZeneca Plc AZN under the brand names Byetta and Bydureon BCise to treat type 2 diabetes.

Also Read: EXCLUSIVE: Vivani Medical Highlights Weight Loss Data For GLP-1 Implant Supporting Potential Veterinary Use.

“The reduction in liver fat observed preclinically with our miniature, subdermal exenatide implant provides further support that the NanoPortal implant technology continues to hold great potential as a highly differentiated treatment option for the treatment of obesity and chronic weight management as well as related metabolic disorders…Our first clinical study, LIBERATE-1, is anticipated to start in the fourth quarter of 2024 with results in 2025,” said Adam Mendelsohn, Vivani President and CEO.

Vivani’s GLP-1 (exenatide) implant produced a sham-implant-adjusted liver fat reduction of 82% in an obese mouse model from a single administration with expected twice-yearly dosing.

These liver fat data are consistent with published results from similar investigations with semaglutide, the active pharmaceutical ingredient in Novo Nordisk A/S’ NVO Ozempic and Wegovy.

Previously reported results from this study in high-fat diet-induced obese mice demonstrated that Vivani’s exenatide implant generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to the weight loss observed in the semaglutide active control arm in the study.

The supratherapeutic doses provided for the exenatide implant (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 June, the FDA cleared Vivani’s Investigational New Drug Application for NPM-119, paving the way for the commencement of the LIBERATE-1 Phase 1 trial.

Price Action: At the last check on Tuesday, VANI stock was trading higher by 7.32% at $1.32 premarketay.

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