Vivani Medical, Inc. announced the U.S. Food and Drug Administration has cleared the Investigational New Drug Application (IND) and lifted the clinical hold on NPM-119 to allow initiation of LIBERATE-1??, a Phase 1 clinical trial to assess 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. LIBERATE-1 is a randomized, 12-week investigation of the safety, tolerability, and full pharmacokinetic profile of NPM-119 in patients with type 2 diabetes. LIBERATE-1 will enroll patients who have previously received GLP-1 therapy, which will be discontinued prior to receiving either NPM-119 or the active comparator.

Vivani continues advancing its emerging pipeline of innovative, highly differentiated drug implants leveraging its proprietary NanoPortal? subdermal implant technology, designed to guarantee medication adherence and improve patient outcomes in the treatment of chronic diseases such as chronic weight management and type 2 diabetes. In addition to NPM-119 for the treatment of type 2 diabetes, Vivani is advancing the development of NPM-115 (high-dose exenatide implant) and NPM-139 (semaglutide implant), both promising treatments under development for chronic weight management.

NPM-139 has the added potential for a once-yearly treatment duration.