Vivani Medical has secured regulatory approval in Australia to commence its first-in-human clinical trial, LIBERATE-1, evaluating a subdermal GLP-1 (exenatide) implant for managing obesity and overweight. The trial will assess the safety, tolerability, and pharmacokinetic profile of the NPM-115 implant, which leverages Vivani's NanoPortal technology for sustained drug delivery over an extended period.
The LIBERATE-1 trial is set to enroll obese and overweight participants who will undergo an initial 8-week titration period with weekly semaglutide injections. Subsequently, participants will be randomized to receive either Vivani’s exenatide implant, weekly exenatide injections, or weekly 1 mg semaglutide injections for a 9-week treatment duration. Weight changes will be closely monitored throughout the study. The trial is expected to begin in the fourth quarter of 2024, with initial data anticipated in 2025.
NanoPortal Technology
Vivani's NanoPortal technology is designed to deliver medication steadily over extended periods, ensuring consistent dosing and potentially improving patient tolerance. This technology is capable of delivering large hydrophilic molecules, including peptides and proteins, broadening its therapeutic applications. The company believes this approach can address medication non-adherence, a significant challenge in chronic disease management.
Potential Benefits and Market Context
Adam Mendelsohn, Ph.D., Vivani President and CEO, stated that preclinical data suggests the GLP-1 implant could offer comparable efficacy to semaglutide, the active ingredient in Ozempic and Wegovy, but with the advantage of twice-yearly administration. This could represent a significant improvement over existing injectable and oral GLP-1 receptor agonists, which require more frequent dosing.
Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths in the U.S. alone. Vivani aims to address this issue with its long-acting implant technology, offering a potentially more convenient and effective treatment option for patients with obesity and overweight.
Trial Design and Regulatory Strategy
The LIBERATE-1 trial is designed as a randomized study to evaluate the safety, tolerability, and pharmacokinetic profile of the exenatide NanoPortal implant. Vivani intends to use data generated in Australia to support regulatory submissions in other regions, including the U.S., as clinical studies conducted in Australia comply with International Conference on Harmonization guidelines and are generally acceptable to the FDA and other regulatory bodies.
