GLP-1 implant NPM-115 enters clinical trials for obesity
Vivani Medical has announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial.
The company hopes to address one of healthcare’s most pressing challenges: medication adherence in metabolic diseases including chronic weight management and type 2 diabetes.
Vivani also announced full enrolment in the LIBERATE-1 study, which was achieved in just four weeks after enrolment of the first subject, reaffirming previous estimates that top-line results should be available in mid-2025.
Adam Mendelsohn, Chief Executive Officer of Vivani, said: “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.
“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 minimise tolerability issues.”
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.
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.
Diana Spencer, Senior Digital Content Editor, DDW
