Vivani Medical Announces Positive Preclinical Weight Loss Data for NPM-139 Semaglutide Implant, with Potential for Once-Yearly Dosing

Core Insights - Vivani Medical, Inc. has announced promising preclinical data for NPM-139, a subdermal semaglutide implant aimed at chronic weight management, showing nearly 20% placebo-adjusted weight loss from a single administration [1][5] - The NanoPortal™ technology is designed to ensure smooth and steady delivery of GLP-1 therapy, potentially improving medication adherence and treatment tolerability [1][10] - The company is also conducting a first-in-human study, LIBERATE-1, for another implant, NPM-115, which is expected to provide critical data for the development of NPM-139 [6][7] Company Overview - Vivani Medical is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants for chronic weight management and other chronic diseases [1][10] - The company’s lead program, NPM-115, is a six-month GLP-1 (exenatide) implant, while NPM-139 is being developed as a semaglutide implant with potential for once or twice-yearly administration [10] - The company aims to address medication non-adherence, which affects approximately 50% of patients, contributing to significant healthcare costs and preventable deaths [10] Market Opportunity - Products containing semaglutide generated $25 billion in 2024, with a growing demand for more convenient delivery options to improve medication adherence [2] - The company believes that its NanoPortal implant technology can transform the adoption of GLP-1 therapy by eliminating missed doses and enhancing health outcomes [2] Clinical Development - The ongoing LIBERATE-1 study is a Phase 1 trial investigating the safety and pharmacokinetics of NPM-115, which will also inform the development of NPM-139 [6][7] - Top-line data from LIBERATE-1 is anticipated by mid-2025, which will be crucial for the future development of both NPM-115 and NPM-139 [6][7] Regulatory and Financial Aspects - Vivani has utilized research and development rebates from the Australian government to offset clinical trial costs and plans to continue leveraging such rebates [8] - Data generated in Australia is expected to support regulatory submissions in other regions, including the United States [8]