Vivani Medical, Inc. (NASDAQ: VANI) has successfully administered its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial, the company announced this week. This milestone represents a significant step in addressing one of healthcare's most pressing challenges: medication adherence in metabolic diseases, including chronic weight management and type 2 diabetes.
The company also reported full enrollment in the LIBERATE-1 study, achieved in just four weeks after the first subject enrollment. This rapid recruitment signals strong potential interest in the six-month, subdermal GLP-1 implant and supports previous estimates that top-line results should be available by mid-2025.
"We are excited to report that the first dose of the NPM-115 implant was successful. The insertion was well tolerated by the subject," said Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. "Combined with the achievement of full enrollment in the study, this represents important progress in advancing our GLP-1 implant through clinical development."
Addressing the Global Obesity Crisis
With obesity affecting more than one billion people globally, Vivani's implant technology aims to redefine treatment paradigms by providing a convenient therapeutic alternative with significantly reduced dosing frequency compared to daily oral medications and weekly injectables.
The company's NanoPortal™ platform technology is designed to improve medication adherence, potentially leading to better patient outcomes. According to real-world data, approximately half of patients regularly miss medication doses, resulting in suboptimal efficacy and possible exacerbation of tolerability issues.
"About half of people regularly miss doses as indicated by real-world medication adherence data," Dr. Mendelsohn explained. "Missed doses not only lead to suboptimal efficacy but can also exacerbate tolerability issues. In fact, manufacturers of marketed, weekly injectable GLP-1 products recommend that a patient consider reinitiating GLP-1 therapy at the initial starting dose if two doses or more are missed, to avoid tolerability issues associated with rapid increases in GLP-1 exposure levels."
LIBERATE-1 Trial Design and Objectives
The LIBERATE-1 study is a Phase 1, first-in-human trial designed to investigate the safety, tolerability, and full pharmacokinetic profile of NPM-115 in obese or overweight subjects. The trial has enrolled participants who will undergo an 8-week titration period on weekly semaglutide injections (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before randomization.
Following titration, subjects will be randomized to receive either:
- A single administration of Vivani's exenatide implant (NPM-115, n=8)
- Weekly exenatide injections (Bydureon BCise®, n=8)
- Weekly 1 mg semaglutide injections (Wegovy®, n=8)
The treatment duration will be 9 weeks, during which changes in weight will be measured. The study is currently ongoing at two centers in Australia.
NPM-115 has demonstrated consistently smooth and minimally fluctuating drug release both in vitro and in animal models. In preclinical studies, it has shown comparable weight loss to injections of semaglutide, the active ingredient in Ozempic® and Wegovy®. Successful translation to humans could potentially demonstrate greater effectiveness and tolerability in otherwise poorly adherent patients.
Expanding Pipeline for Metabolic Diseases
Beyond NPM-115, Vivani's emerging pipeline includes NPM-139, a semaglutide implant also under development for chronic weight management in obese and overweight individuals. This implant has the potential benefit of once-yearly administration, further reducing the frequency of required treatments.
Additionally, NPM-119 refers to the company's six-month, subdermal, GLP-1 (exenatide) implant under development specifically for the treatment of type 2 diabetes.
These NanoPortal implants are designed to help patients realize the full potential benefit of their medication by avoiding challenges associated with daily or weekly administration of conventional treatments. Medication non-adherence contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone.
Market Context and Future Outlook
While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani remains confident that its highly differentiated portfolio of miniature long-acting GLP-1 implants can provide an attractive therapeutic option for patients, prescribers, and payers.
The company intends to utilize research and development incentives and rebates from the Australian government to defray a portion of the costs from this clinical trial. Since clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines, data generated there are generally acceptable to the U.S. Food and Drug Administration and other regulatory authorities.
With the successful first implant and full enrollment achieved, Vivani appears well-positioned to advance its innovative approach to metabolic disease treatment, potentially addressing critical adherence issues while providing a convenient alternative to current therapies.
