Vivani Medical (Nasdaq: VANI) has announced a major milestone in its LIBERATE-1 clinical trial: the successful administration of its first GLP-1 implant. This development comes just one day after Vivani revealed plans to spin off its neurostimulation business, focusing on advancing its GLP-1 implants. The company also confirmed that full enrollment in the LIBERATE-1 trial has been completed, just four weeks after the first participant was enrolled. Vivani expects to have top-line results by mid-2025.
The LIBERATE-1 trial, which began in late 2024, is being conducted at two centers in Australia. The study will evaluate the effectiveness of the miniature GLP-1 implant in treating obesity and overweight conditions.
This follows the FDA’s approval of Vivani’s investigational new drug (IND) application for the implant in June 2024.
Vivani’s NPM-115 implant has shown consistent and stable drug release in both lab and animal models. The company anticipates that this stability will translate into better outcomes for patients, especially those who struggle with medication adherence. The implant is expected to have a positive impact on the treatment of type 2 diabetes and other related conditions.
The NPM-115 implant uses Vivani’s proprietary NanoPortal technology, which is designed to deliver medication steadily over long periods. This technology helps ensure correct dosing while reducing safety risks linked to fluctuating drug release. Additionally, it is capable of delivering large molecules like peptides and proteins, broadening its potential for various treatments.
Vivani Medical CEO Adam Mendelsohn expressed his excitement about the trial’s progress, saying, “We are thrilled with the success of the first NPM-115 implant dose. The procedure was well-tolerated, and completing full enrollment in the study marks significant progress in advancing our GLP-1 implant through clinical development. With obesity affecting over one billion people worldwide, our implant offers a new, more convenient treatment option with fewer doses compared to daily pills or weekly injections.”
Mendelsohn also highlighted the potential of Vivani’s NanoPortal technology to improve medication adherence. “Approximately half of patients miss doses, which leads to reduced efficacy and can worsen side effects,” he said. “Our long-acting implants could help address this issue, potentially improving patient outcomes and minimizing tolerability problems. For example, some weekly injectable GLP-1 medications recommend restarting treatment at the original dose if two or more doses are missed. Our implants are designed to avoid such issues, offering a more stable and effective treatment.”
