GLP-1 implant NPM-115 meets primary endpoint
- owenhaskins
- Aug 7
- 3 min read
Vivani Medical has revealed that results from the LIBERATE-1 clinical study, a Phase 1 study of the exenatide GLP-1 implant NPM-115 representing the first-in-human test of NanoPortal implant technology, has shown it successfully met its primary objectives, which were to evaluate the NPM-115 implant’s safety and tolerability profile and to characterise the pharmacokinetic (PK) profile of the implant over a nine-week duration.
Throughout the study, the implant was generally well tolerated, and drug release from the implant without any clinically meaningful burst was supported by PK analysis and by the absence of gastrointestinal adverse events in subjects with the implant. No serious adverse events were observed in the study. The release profile observed from the implants over nine weeks provides encouragement regarding the potential for this technology to provide durable delivery over the six-month duration that has already been established in preclinical studies of both NPM-115 and NPM-139.
Vivani also reported new feasibility data for NPM-139 (semaglutide implant) from an ongoing preclinical study, supporting prioritization of the semaglutide implant in the company’s pipeline and clinical development strategy.
“We are very pleased to report that LIBERATE-1, our Phase 1 study in obese and overweight subjects and the first clinical application of NanoPortal technology, achieved its primary objectives,” said Vivani’s Chief Executive Officer, Dr Adam Mendelsohn. “The results support the general safety and tolerability profile of the device and continued development with higher dose configurations, which we expect to produce clinically relevant weight management effects. In addition to the LIBERATE-1 results, we are very excited to report new preclinical feasibility data with our semaglutide implant candidate NPM-139, under development for chronic weight management which have shown approximately 20% weight loss with a single administration for over 6 months and continue to show potential for annual dosing. When we couple the successful completion of the LIBERATE-1 study with the new feasibility data for our semaglutide implant, it is an easy decision to focus our resources and prioritize efforts to accelerate NPM-139 into clinical-stage development.”
The decision to prioritise NPM-139 is supported by several factors. These include the company’s belief that the development timelines for the NPM-115 and NPM-139 programs are comparable, the increased confidence in NPM-139 due to the fact that semaglutide products have already established compelling weight loss data in humans, and the strong commercial performance of semaglutide-based products, including Ozempic, Wegovy, and Rybelsus, which have generated over $29B in sales in 2024 and are expected to have continued growth into the foreseeable future.
This study paves the way for future clinical development of the implant technology not just for exenatide (NPM-115 and NPM-119) but also for semaglutide (NPM-139) and any other application of NanoPortal technology that Vivani may pursue in the future.
In an ongoing preclinical study, substantial progress in the development of a miniature, ultra long-acting, semaglutide implant, NPM-139 has been established by showing weight loss from a single administration for over 231 days (Figure1).
While the emerging preclinical data on the company’s semaglutide implant currently supports the initial target profile of bi-annual dosing, the company continues to anticipate that a semaglutide implant candidate may be able to support annual dosing in the future. Vivani’s near-term efforts are focused on completion of PK optimization activities and preparation of data to enable the submission of an Investigational New Drug application for NPM-139.