This news comes just one day after Vivani announced plans to spin off its neurostimulation business to focus on its GLP-1 implants. The company also announced full enrollment in LIBERATE-1, achieved in just four weeks after the first enrollment. It expects top-line results available in mid-2025.
Alameda, California-based Vivani initiated its LIBERATE-1 trial at two centers in Australia at the end of 2024. The study will evaluate the miniature GLP-1 implant in obese and overweight subjects.
This study follows FDA approval for an investigational new drug (IND) application for the company’s implant in June 2024.
Vivani says NPM-115 has demonstrated smooth and minimally fluctuating drug release both in vitro and in animal models. The company said it expects successful translation to humans to demonstrate greater effectiveness and tolerability in otherwise poorly adherent patients. It expects results to support the application of the implant in the treatment of type 2 diabetes and other diseases.
NPM-115 utilizes the company’s proprietary NanoPortal drug implant technology. Vivani designed NanoPortal technology to steadily deliver medication over extended periods of time. The company aims to guarantee correct doses for patients while avoiding potential safety concerns around fluctuating drug release profiles. It can also deliver large hydrophilic molecules, including peptides and proteins. The company believes this enables a broader range of therapeutic applications.
Commentary from Vivani Medical officials
Vivani CEO Adam Mendelsohn said in a news release:
“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 enrollment in the study, this represents important progress in advancing our GLP-1 implant through clinical development. 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.
“We also believe our innovative NanoPortal platform technology could improve medication adherence and thereby significantly improve patient outcomes. 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. In fact, manufacturers of marketed, weekly injectable GLP-1 products recommend that a patient consider reinitiating GLP-1 therapy at the initial starting dose if two doses or more are missed, to avoid tolerability issues associated with rapid increases in GLP-1 exposure levels. We believe our miniature, ultra long-acting implants, designed to improve medication adherence, have the potential to improve efficacy and minimize tolerability issues.”
