ALAMEDA, Calif. - Vivani Medical (TASE:PMCN), Inc. (NASDAQ: VANI), a biopharmaceutical company with a market capitalization of $71.67 million, has commenced the first-in-human clinical trial for its GLP-1 (exenatide) implant, a significant advancement in the treatment of obesity. The trial, named LIBERATE-1, is being conducted in Australia and marks the initial clinical application of the company's proprietary NanoPortal™ drug implant technology. According to InvestingPro data, the stock has gained over 18% year-to-date, though analysts note significant growth potential with price targets ranging from $3 to $8.
LIBERATE-1 aims to evaluate the safety, tolerability, and pharmacokinetic profile of the exenatide implant in overweight or obese participants. The study involves pre-treatment with semaglutide injections before randomization to one of three groups: a single administration of Vivani’s exenatide implant, weekly exenatide injections, or weekly semaglutide injections, with changes in weight as a primary measure.
Vivani's President and CEO, Adam Mendelsohn, Ph.D., highlighted the potential of the GLP-1 implant to offer efficacy comparable to semaglutide but with the added convenience of twice-yearly administration. The company's drug implants are designed to combat medication non-adherence, a significant challenge in chronic disease management.
The trial's top-line data is expected in mid-2025. Vivani plans to leverage Australian government incentives to offset some costs and anticipates using the trial data to support regulatory submissions in various regions, including the United States.
Vivani Medical specializes in developing long-acting biopharmaceutical implants, with its lead program focusing on chronic weight management. The company's portfolio also includes a semaglutide implant, potentially administered once yearly, and a type 2 diabetes program featuring a six-month exenatide implant.
This announcement contains forward-looking statements, including the therapeutic potential of Vivani's products and planned development activities. These statements are based on current beliefs and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. InvestingPro subscribers have access to detailed financial analysis and additional insights, including 7 more ProTips about Vivani's financial health and market position. The information in this article is based on a press release statement.
In other recent news, Vivani Medical has made substantial strides in its clinical trials and corporate governance. The biopharmaceutical company received approval for its inaugural human clinical trial in Australia, testing the safety and pharmacokinetics of a newly developed GLP-1 (exenatide) implant for overweight and obese individuals. The trial, named LIBERATE-1, will be the first to apply Vivani's NanoPortal drug implant technology, aiming to enhance patient adherence to medication regimes through twice-yearly administration.
The company's Annual Meeting of Stockholders resulted in the re-election of six directors and the ratification of BPM LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2024. Concurrently, Vivani Medical received FDA approval for the Phase 1 clinical trial of its diabetes treatment implant, NPM-119, marking the company's transition into a clinical-stage company.
These are part of the recent developments in Vivani Medical's pursuit to address chronic diseases. The company's pipeline also includes long-acting implants like the NPM-139 (semaglutide) implant, which may offer annual administration, and the NPM-119 for Type 2 Diabetes management. These developments are in line with Vivani's strategy to address the widespread issue of medication non-adherence, which poses significant health and economic burdens.
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