ALAMEDA, Calif. - Vivani Medical, Inc. (NASDAQ:VANI), a biopharmaceutical company, has announced positive preclinical results for its innovative obesity treatment implants, NPM-115 and NPM-139. These implants, which release medication over extended periods, are designed to improve patient adherence and potentially enhance treatment tolerability.
NPM-115, an exenatide implant intended for twice-yearly administration, has shown significant weight loss effects in preclinical studies, with results comparable to those achieved with semaglutide injections, a current standard in obesity treatment. Vivani also revealed that semaglutide is the key ingredient in NPM-139, which offers the potential advantage of once-yearly dosing.
In a recent study involving obese mice on high-fat diets, NPM-115 induced a weight loss of about 20% over 28 days, similar to the weight reduction seen with semaglutide injections. Another study in healthy rats demonstrated that a single administration of NPM-119, a related exenatide implant developed for type 2 diabetes, resulted in approximately 25% lower body weight compared to controls after 15 weeks.
Vivani's CEO, Adam Mendelsohn, Ph.D., emphasized the strategic shift towards obesity implants due to their potential to improve health outcomes. He cited a large retrospective cohort study, which reported only 40% adherence and persistence for current obesity medications, underscoring the need for better solutions.
The company plans to submit additional chemistry, manufacturing, and controls information to the FDA in the first half of 2024 to address a clinical hold on its NPM-119 study. Meanwhile, preparations are underway for a first-in-human study of NPM-115 for chronic weight management later this year.
Vivani's NanoPortal™ technology underpins the development of these implants, aiming to ensure consistent drug delivery and address the widespread issue of medication non-adherence, which is linked to significant healthcare costs and preventable deaths.
These developments follow the submission of an Investigational New Drug (IND) application for NPM-119's first-in-human study, LIBERATE-1, which is currently on hold. Vivani is also exploring strategic options for its subsidiary Cortigent's neurostimulation systems, which aim to assist patients in regaining critical body functions.
Dr. Mendelsohn is slated to present the study results at the TIDES USA 2024 conference on May 17 in Boston.
This article is based on a press release statement from Vivani Medical, Inc.
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