Vivani Medical Updates on GLP-1 Obesity Implant Program NPM-115

Vivani Medical, Inc., a biopharmaceutical company listed on Nasdaq under the ticker symbol VANI, has announced its plans to commence the first clinical study in its NPM-115 program in the fourth quarter of 2024, pending regulatory clearance in Australia. The NPM-115 clinical program aims to develop a 6-month GLP-1 (exenatide) NanoPortal implant designed for chronic weight management in obese or overweight patients.

Adam Mendelsohn, Ph.D., President and CEO of Vivani, highlighted the company's shift in focus towards treating obesity and chronic weight management due to significant medical needs and substantial market demand. The LIBERATE-1 study, expected to start later this year in Australia, will enroll obese or overweight patients to assess the safety, tolerability, and pharmacokinetics of the exenatide NanoPortal implant. This study is intended to support the development of the NPM-115 program and may also provide clinical validation for Vivani's NanoPortal drug delivery technology.

LIBERATE-1 will be a randomized trial involving patients who will first undergo an 8-week titration period with weekly semaglutide injections (Wegovy®). Patients will then be randomized into three groups: those receiving a single administration of Vivani’s exenatide implant, those receiving weekly exenatide injections (Bydureon BCise®), and those on weekly semaglutide injections. The trial aims to measure changes in weight over a 9-week treatment period, expecting exenatide exposure levels in the implant group to be comparable to those receiving Bydureon BCise.

Previous announcements by Vivani have set the stage for this trial. On February 28, 2024, the company revealed positive preclinical weight loss data from its exenatide implant, comparable to the effects of semaglutide injections, leading to a strategic focus on its obesity portfolio. On June 13, 2024, the FDA cleared Vivani’s Investigational New Drug application for the exenatide implant to be studied in patients with type 2 diabetes under the NPM-119 program. However, due to the shift towards obesity treatment, the NPM-115 study will be prioritized.

Vivani is preparing to submit an application to a Human Research Ethics Committee in Australia to initiate the first-in-human study under the NPM-115 program. The company plans to leverage research and development incentives and rebates from the Australian government to offset some of the trial costs. Clinical studies in Australia, which comply with International Conference on Harmonization guidelines, produce data acceptable to the FDA and other regulatory authorities, making it possible for Vivani to use this data for regulatory submissions in other regions, including the US.

Dr. Mendelsohn emphasized that the results of the LIBERATE-1 study might pave the way for subsequent studies exploring higher and potentially more effective doses of the exenatide implant. Once the optimal dose is identified, further studies will investigate the implant's long-term effects over a six-month period, during which preliminary results in preclinical models have shown promise.

Vivani's strategic shift and forthcoming clinical trials underscore its commitment to addressing the growing issue of obesity with innovative, long-term treatment options, potentially broadening the application of its NanoPortal technology to other chronic diseases.