First human implant of GLP-1 Implant NPM-115

Vivani Medical has announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial, marking a critical step toward medication adherence in metabolic diseases including chronic weight management and type 2 diabetes. The company also announced full enrolment in the LIBERATE-1 study, which was achieved in just four weeks after enrolment of the first subject, signalling early potential interest for this six-month, subdermal GLP-1 implant and reaffirming previous estimates that top-line results should be available in mid-2025. The implant is based on the company's NanoPortal platform technology.

NanoPortal platform technology (Credit: Vivani Medical)

“We are excited to report that the first dose of the NPM-115 implant was successful. The insertion was well tolerated by the subject. Combined with the achievement of full enrolment in the study, this represents important progress in advancing our GLP-1 implant through clinical development,” said Vivani Chief Executive Officer, Dr Adam Mendelsohn. “With obesity affecting more than one billion people globally, our implants could redefine treatment paradigms by providing a convenient therapeutic alternative with significantly reduced dosing frequency compared to daily orals and weekly injectables.

The LIBERATE-1 study is exploring the full pharmacokinetic profile of NPM-115, which has demonstrated consistently smooth and minimally fluctuating drug release both in vitro and in animal models. Successful translation to humans is expected to ultimately demonstrate greater effectiveness and tolerability in otherwise poorly adherent patients, potentially providing a transformative option for chronic weight management patients. Vivani expects these results to support the potential application of this GLP-1 (exenatide) implant in the treatment of type 2 diabetes and other diseases for which GLP-1 treatment has demonstrated, or will demonstrate, clinical benefit.

LIBERATE-1 is a Phase 1, first-in-human study of a miniature, ultra long-acting GLP-1 (exenatide) implant to investigate the safety, tolerability, and full pharmacokinetic profile in obese or overweight subjects. The trial will enrol participants who will be titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomised to receive a single administration of Vivani’s exenatide implant (NPM-115, n=8), weekly exenatide injections (Bydureon BCise, n=8), or weekly 1 mg semaglutide injections (Wegovy, n=8) for a nine-week treatment duration. Changes in weight will be measured. The study is currently on-going at two study centres in Australia and is fully enrolled. Top-line data from the study is anticipated to be available in mid-2025.

If available, Vivani intends to utilise research and development incentives and rebates from the Australian government to defray a portion of the costs from this clinical trial. Since clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines, data generated in Australia generally are acceptable to the FDA and other regulatory authorities. Vivani anticipates use of relevant clinical data generated in Australia to support regulatory submissions in other geographies including the US. Additional guidance regarding future regulatory submissions will be provided as new information becomes available.