Vivani Medical Inc. VANI expects to initiate the first clinical study for the NPM-115 program in Australia in the fourth quarter of 2024.
The NPM-115 clinical program will evaluate the investigational 6-month GLP-1 implant for chronic weight management in patients who are either obese or overweight with a related comorbidity.
LIBERATE-1 will be a randomized investigation of the safety, tolerability, and pharmacokinetic profile of the exenatide NanoPortal implant in obese or overweight patients.
Related: Vivani Medical Highlights Weight Loss Data For GLP-1 Implant Supporting Potential Veterinary Use.
The study will enroll patients who will be titrated on weekly semaglutide injections for eight weeks (0.25 mg/week for four weeks followed by 0.5 mg/week for four weeks) before being randomized to receive a single administration of Vivani’s exenatide implant (n=8), weekly exenatide injections Bydureon BCise (n=8), or weekly 1 mg semaglutide injections (n=8) for 9-week treatment duration.
Semaglutide is an active ingredient used in Novo Nordisk A/S’s NVO Wegovy and Ozempic.
The exenatide implant used in LIBERATE-1 is expected to produce exenatide exposure levels comparable to those of Bydureon BCise.
Weight changes will be measured. The trial is expected to initiate later this year, and data are projected to be available in 2025.
In February, Vivani announced preclinical weight loss data from its exenatide implant, comparable to semaglutide injections, supporting its NPM-115 development program and a strategic shift to prioritize its obesity portfolio.
In June, the FDA cleared Vivani’s Investigational New Drug for its exenatide implant to be studied in patients with type 2 diabetes.
The company previously announced an intention to initiate the first study in the NPM-119 program in the second half of this year.
As a result of reprioritizing the focus of its GLP-1 implants on the treatment of obesity and chronic weight management, the company plans to pursue the NPM-115 study first.
Price Action: VANI shares closed at $1.25 on Wednesday.
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