A day after announcing a business split-off to focus on weight loss and diabetes implants, Vivani Medical has implanted the first patient with its device.
The procedure is part of a first-in-human clinical trial in Australia called LIBERATE-1 (NCT05670379) evaluating the implant in obese or overweight individuals. The company’s other implant called NPM-119 is being developed for type 2 diabetes treatment.
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Shares in the Nasdaq-listed company rose by 5% at market open compared to a pre-announcement market close. Shares in Vivani were already elevated after it revealed plans yesterday to spin-off its neurostimulation business Cortigent as a publicly traded company. The move is expected to facilitate both companies prioritising their respective product pipelines.
The NPM-115 device is a miniature sub-dermal implant that delivers exenatide, a glucagon-like peptide-1 receptor agonist (GLP-1RA). Vivani says the drug has demonstrated good drug release both in vitro and in animal models. The implant is designed to last for six months.
The LIBERATE-1 study, which Vivani also revealed is now fully enrolled, is investigating NPM-115’s safety, tolerability, and full pharmacokinetic profile in obese or overweight subjects. Participants will first be given injections of Novo Nordisk’s popular GLP-1RA medication Wegovy (semaglutide) for two months, then one of three treatments – Vivani’s implant, weekly injections of AstraZeneca’s branded exenatide medication for diabetes Bydureon BCise, or weekly Wegovy doses. Vivani will assess changes in weight through a nine-week duration, with top-line data slated to be available in mid-2025.
GLP-1RAs have become one of the dominant forces in the pharmaceutical sector. Wegovy is forecast to generate sales of $19.4bn by 2030, according to analysis by GlobalData. Eli Lilly’s rival compound Zepbound (tirzepatide), which has demonstrated slightly better efficacy, is predicted to go even further, seeing sales of $25.2bn by the same year.
Whilst their use has skyrocketed amongst overweight patients, the necessity for regular injections has been a source of adherence issues. A real-world study on just under 4,800 patients on GLP-1RA medication found that around half were non-adherent.
Vivani believes its long-lasting drug candidate could provide an alternative option that improves medication adherence and reduces administration burden.
Vivani’s CEO Adam Mendelsohn said: “About half of people regularly miss doses as indicated by real-world medication adherence data.
“Missed doses not only lead to suboptimal efficacy but can also exacerbate tolerability issues. We believe our miniature, ultra long-acting implants, designed to improve medication adherence, have the potential to improve efficacy and minimise tolerability issues.”
