Vivani issues positive preclinical weight loss data for NPM-139 semaglutide implant

Vivani Medical has announced promising preclinical data for NPM-139, its subdermal semaglutide implant under development for chronic weight management in people with obesity and overweight. These results reinforce the company’s commitment to addressing chronic weight management and other chronic diseases by leveraging its proprietary NanoPortal implant technology which is designed to enable smooth and steady delivery of therapeutic molecules including GLP-1 therapy.

Weight difference versus control group in healthy Sprague-Dawley Rats. % weight change from baseline for NPM-139 (semaglutide) corrected to control (sham implant). Values are mean ± SE.

In an ongoing study in healthy rats, a single administration of the semaglutide implant NPM-139 resulted in body weights that were nearly 20% lower than a sham implant control group throughout a 91-day treatment period. Like NPM-119 and NPM-115, NPM-139 has demonstrated smooth, non-fluctuating in vivo release; this was confirmed by pharmacokinetic data from this study which demonstrated continuous and steady semaglutide exposure throughout the study period.

NPM-139 has previously demonstrated therapeutic semaglutide exposure levels in pharmacokinetic data over a six-month duration in healthy rats. In vitro chemical and physical stability measurements for durations exceeding one year indicate the potential for once-yearly administration of NPM-139. Together, these data demonstrate the versatility of the NanoPortal technology beyond NPM-115 (exenatide implant) and provide significant encouragement for continued development of each programme.

The ongoing NPM-115 clinical study, LIBERATE-1, for which the first successful implantation was recently announced, remains on track to produce top-line data by mid-2025. While LIBERATE-1 will primarily inform continued development of NPM-115, LIBERATE-1 will also provide critical information to support the development of NPM-139 and other pipeline programs since it represents the first human application of the NanoPortal technology.

LIBERATE-1 is a Phase 1, first-in-human study of a miniature, ultra long-acting GLP-1 (exenatide) implant, NPM-115, to investigate the safety, tolerability, and full pharmacokinetic profile in people with obesity and overweight subjects. The trial has enrolled participants who are intended to 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 randomized 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 9-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.

Vivani has successfully utilized research and development rebates from the Australian government for relevant 2024 expenses to defray a portion of the costs from this clinical trial and anticipates being able to utilize similar rebates going forward. 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.

“Products containing semaglutide generated $25 billion in 2024 and demand for these products continues to soar. Since over half of these patients regularly miss doses as indicated by real-world medication adherence data, we believe that there is a tremendous opportunity for a more convenient delivery option that will eliminate missed doses and thereby improve real-world health outcomes. We continue to believe that the primary expected advantages of our proprietary NanoPortal implant technology, improving medication adherence and medication tolerability, have the potential to transform and expand the adoption of GLP-1 therapy in the future,” said Dr Adam Mendelsohn, Vivani Medical’s Chief Executive Officer. “This preclinical demonstration of NPM-139 comes on the heels of having rapidly enrolled and successfully implanted an initial group of subjects in LIBERATE-1, our first-in-human study with NPM-115, which we expect will pave the road for NPM-139 as development continues for both programmes.”