Vivani Medical Eyes August Human Trial for Semaglutide Implant After Novo Nordisk Deal

Vivani Medical plans to begin first dosing in its SLIM-1 human trial of a semaglutide implant in August, with the study initially focused on safety, tolerability, pharmacokinetics and early weight-loss signals. The company recently struck an agreement with Novo Nordisk, which will evaluate Vivani’s implant technology, a move CEO Adam Mendelsohn called a significant milestone and an early sign of big pharma interest in implant-based GLP-1 delivery. Vivani is positioning its NanoPortal implant as a way to improve GLP-1 adherence through very infrequent dosing, potentially once or twice a year, while also expanding the platform beyond obesity to diabetes and other next-generation incretin drugs. Vivani Medical said it is preparing to begin human testing of its semaglutide implant in August and highlighted a recently announced agreement with Novo Nordisk to evaluate the company’s implant technology. Adam Mendelsohn, co-founder, CEO and director of Vivani Medical, said the past several months have been “some of the most exciting” in the company’s history, citing the Novo Nordisk agreement as a key recent development. Vivani is developing biopharmaceutical implants using its proprietary NanoPortal platform, designed to deliver drug molecules steadily over extended periods. Mendelsohn said Vivani is focused on the obesity and GLP-1 market, where drugs have enabled significant weight loss and potential long-term health benefits. He said Vivani’s implant approach is intended to provide “very infrequent administration,” potentially once or twice a year, while retaining the ability to stop treatment quickly through implant removal. He contrasted the company’s approach with longer-acting injectables and gene-editing approaches, saying Vivani’s implant could offer convenience while addressing issues tied to missed doses and treatment discontinuation. Mendelsohn said the company expects the implant could improve real-world outcomes by “essentially guaranteeing adherence” and delivering stable drug levels over time. Vivani’s lead GLP-1 program is NPM-139, a semaglutide implant. Semaglutide is the active ingredient in Ozempic and Wegovy. Mendelsohn said the company is developing the implant to deliver semaglutide for six or potentially 12 months. Mendelsohn said Vivani recently announced an agreement with Novo Nordisk under which Novo Nordisk will evaluate Vivani’s semaglutide implant. He described the agreement as notable, saying that, to Vivani’s knowledge, it represents the first public indication of potential big pharma interest in an implant modality for GLP-1s. “To our knowledge, we are the only company that's actively developing such a solution,” Mendelsohn said during the presentation. He said Vivani has made “considerable progress” developing the semaglutide implant and is looking ahead to both its upcoming clinical trial results and Novo Nordisk’s evaluation. Mendelsohn said Vivani is now projecting first dosing in its SLIM-1 clinical trial to occur in August. The company received regulatory approval to begin the study in June, he said. The initial study is designed to assess translation from animal models to humans using a low dose. Mendelsohn said Vivani selected an implant dose intended to match the starting dose of the Wegovy titration sequence, approximately 0.25 milligrams per week for a four-week duration. The study is expected to assess safety, tolerability and pharmacokinetics, while also measuring weight loss.