Vivani Medical (VANI) announced plans to initiate a Phase 1 clinical study in the NPM-139 semaglutide implant program in the first half of 2026, pending regulatory clearance. The Company is also preparing to initiate a Phase 2 clinical study of NPM-139 pending enabling results from the Phase 1 study and regulatory feedback. “Recent promising results from LIBERATE-1, the first-in-human study of NPM-115, an exenatide implant utilizing NanoPortal technology, combined with positive preclinical weight loss data with NPM-139, compel us to move forward aggressively with clinical development of NPM-139. The Phase 1 study, designed to evaluate the safety, tolerability and pharmacokinetic profile of the semaglutide implant and to enable a Phase 2 efficacy study, is expected to initiate in the first half of 2026, pending regulatory clearance,” said Vivani President and Chief Executive Officer Adam Mendelsohn, Ph.D. “The overall GLP-1 market in weight management continues to grow at an impressive rate, primarily because of considerable unmet medical needs and the fact that current GLP-1 options have a much better safety and efficacy profile compared to medications previously approved to treat obesity. We believe that NPM-139 could provide clear and compelling differentiation due to its potential to provide Wegovy-level efficacy with convenient once or twice-yearly administration.”
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