Vivani Medical, Inc. (NASDAQ: VANI), a clinical-stage biopharmaceutical company specializing in miniature, ultra-long-acting drug implants, has announced it will accelerate the development of its NPM-139 semaglutide implant following encouraging preclinical results showing sustained weight loss. The decision comes alongside positive findings from the LIBERATE-1 Phase 1 trial of its NPM-115 exenatide implant, which validated the company’s proprietary NanoPortal™ implant technology in humans for the first time.
The LIBERATE-1 trial, conducted in overweight and obese individuals, achieved its primary objectives by confirming the safety, tolerability, and stable drug release profile of the NPM-115 implant over a nine-week period. No serious adverse events were reported, and pharmacokinetic data supported the implant’s potential to provide durable drug delivery over several months, as previously demonstrated in preclinical studies.
Building on this success, Vivani highlighted new preclinical feasibility data for NPM-139, designed to deliver semaglutide, the active ingredient in widely prescribed weight-loss drugs Ozempic®, Wegovy®, and Rybelsus®. A single administration of NPM-139 in animal studies resulted in approximately 20% weight loss sustained for more than six months, with data suggesting the potential for twice-yearly or even annual dosing in the future.
CEO Adam Mendelsohn, Ph.D., stated that prioritizing NPM-139 is a strategic move given semaglutide’s proven clinical efficacy in humans, strong commercial demand exceeding $29 billion in 2024 sales, and Vivani’s belief that development timelines for NPM-115 and NPM-139 remain similar. The company now plans to focus on pharmacokinetic optimization and regulatory preparations to submit an Investigational New Drug (IND) application for NPM-139 in the near future.
Vivani sees NPM-139 as a potential long-acting, convenient alternative to weekly GLP-1 injections, offering a new option for chronic weight management in a rapidly expanding market.
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