Implant device for obesity set for local clinical trial

MedTech & Diagnostics News: The first in-human trial of a long-acting GLP-1 implant for chronic weight management is set to launch in Australia this year.

Vivani Medical is expected to commence the local trial in the fourth quarter, pending regulatory approval. The NPM-115 program will investigate a six-month GLP-1 implant designed for patients who are obese or overweight with related comorbidities.

This development coincides with Novo Nordisk’s Wegovy (semaglutide 2.4mg), a once-weekly GLP-1 receptor agonist, now available in Australia. With two-thirds of Australians struggling with obesity or overweight, costing the country $12 billion annually, Wegovy represents a critical advancement in addressing this pressing clinical need.

Vivani’s core technology is its NanoPortal device, a tiny titanium cylinder with a reservoir for medication. Drugs are released through nanotubes with pores that are sized according to how quickly or slowly the medication should be delivered. The device is placed under the skin, where it secretes drugs for six months before being replaced. Vivani is working on another implant, NPM-139, that secretes semaglutide for up to a year.

The company has also received FDA approval for a separate clinical trial for NPM-119, another six-month GLP-1 implant targeting type 2 diabetes.

Both NPM-115 and NPM-119 will use the company’s NanoPortal implant technology, which delivers medication over extended periods to ensure consistent dosing and minimise safety risks associated with fluctuating drug release.

“In February, our company announced that we were re-prioritizing the development of our GLP-1 implants to focus on the treatment of obesity and chronic weight management in response to the significant medical need and unprecedented market demand,” said Adam Mendelsohn, Vivani president and CEO.

“Today we can report that our first-in-human study, LIBERATE-1, is expected to enrol patients who are obese or overweight to primarily support NPM-115’s development program. We anticipate initiating this clinical study in Australia later this year.”

The technology can also deliver large hydrophilic molecules, including peptides and proteins.

Mendelsohn also said the company believes the results of the trial “may provide clinical validation of our NanoPortal drug delivery technology to support a broader application of the technology in the treatment of chronic diseases.”

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