The LIBERATE-1 trial will evaluate the miniature GLP-1 (exenatide) implant in obese and overweight subjects. This follows FDA approval for an investigational new drug (IND) application for the company’s implant in June. The FDA lifted the clinical hold on Vivani’s NPM-119, allowing the initiation of its LIBERATE-1 Phase 1 clinical trial. This trial looks at the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the company’s miniature, six-month GLP-1 implant in development for the treatment of type 2 diabetes.
Vivani’s implant utilizes the company’s proprietary NanoPortal drug implant technology. Alameda, California-based Vivani designed NanoPortal technology to steadily deliver medication over extended periods of time. The company aims to guarantee correct doses for patients while avoiding potential safety concerns around fluctuating drug release profiles. It can also deliver large hydrophilic molecules, including peptides and proteins. The company believes this enables a broader range of therapeutic applications.
According to Vivani, it expects to initiate its trial later this year, with data set for publication in 2025. The company could use relevant data generated in Australia to support regulatory submissions elsewhere, including in the U.S.
“Securing regulatory approval keeps us on schedule to initiate this trial in Australia in the fourth quarter of 2024,” said Adam Mendelsohn, Vivani president and CEO. “Preclinical weight loss and liver fat data announced earlier this year supports the potential for our GLP-1 implant to provide comparable efficacy to semaglutide, the active ingredient in blockbuster products Ozempic and Wegovy, but with the significant benefit of twice-yearly administration. We remain confident that our emerging portfolio of miniature, ultra long-acting, GLP-1 implants has the potential to be highly differentiated from the injectable and oral products in the market and in development.
