Vivani Medical, Inc. (Nasdaq: VANI), an innovative biopharmaceutical company specializing in novel, ultra long-acting drug implants, today announced the initiation of screening and enrollment for its first-in-human clinical trial, LIBERATE-1™, at two centers in Australia. The trial aims to evaluate the safety, tolerability, and pharmacokinetic profile of an exenatide implant. This study marks the first clinical use of Vivani’s proprietary NanoPortal™ drug implant technology.
Vivani Medical, Inc. (Nasdaq: VANI), a biopharmaceutical company focused on innovative, long-acting drug implants, has announced a major milestone: the transition to clinical-stage development. The company has initiated its first human clinical trial, LIBERATE-1™, to assess the safety, tolerability, and pharmacokinetic profile of its exenatide NanoPortal™ implant in obese and overweight individuals. This step will help determine if the promising results seen in animal studies can be replicated in humans.
Dr. Adam Mendelsohn, Vivani’s President and CEO, shared his excitement about the company’s progress. “This is a major milestone for our company, and it will allow us to determine if the very encouraging results from our animal studies will translate to overweight or obese study subjects,” he said. He further emphasized that preclinical data on weight loss and liver fat reduction supports the potential for the GLP-1 implant to match the efficacy of semaglutide, with the significant advantage of only needing to be administered twice a year.
Vivani’s innovative approach combines its NanoPortal™ platform technology with its portfolio of ultra long-acting GLP-1 implants. The company believes these implants offer a solution to medication non-adherence—a key challenge for many patients—by providing extended-release medications that require far less frequent administration. According to Dr. Mendelsohn, this technology has the potential to improve real-world health outcomes and provide significant convenience to patients by reducing the need for daily or weekly injections.
The LIBERATE-1 trial is a randomized study that will involve obese and overweight participants. In the study, subjects will first receive weekly semaglutide injections for eight weeks. After that, they will be randomized to receive either a single exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for a nine-week treatment period. The trial will measure changes in weight, and the company expects top-line data to be available by mid-2025.
To help offset some of the costs of this clinical trial, Vivani plans to take advantage of research and development incentives and rebates offered by the Australian government. Since clinical studies conducted in Australia adhere to the International Conference on Harmonization guidelines, data from these studies are generally accepted by the U.S. Food and Drug Administration (FDA) and other global regulatory bodies. Vivani intends to use the data generated in Australia to support regulatory submissions in other markets, including the United States.
About Vivani Medical, Inc.
Vivani Medical is advancing biopharmaceutical implants utilizing its NanoPortal™ platform, designed to deliver drugs steadily over extended periods. The company’s lead program, NPM-115, is a six-month, subdermal exenatide implant under development for chronic weight management in obese and overweight individuals. Vivani is also developing the NPM-139 semaglutide implant, which could offer the added benefit of once-yearly administration. Vivani’s portfolio targets a significant unmet need in chronic disease management by addressing medication non-adherence, which affects about 50% of patients and contributes to over $500 billion in annual avoidable healthcare costs in the U.S. alone. Vivani’s implants offer a more convenient and effective alternative to daily or weekly oral or injectable medications, making them a potentially transformative solution for patients with obesity, type 2 diabetes, and other chronic conditions.
