FDA Approves Vivani Medical's NPM-119 GLP-1 Drug Implant

In a significant development for the treatment of type 2 diabetes, Vivani Medical, Inc., a biopharmaceutical firm known for its long-term drug implants, has received clearance from the U.S. Food and Drug Administration (FDA) to commence clinical trials for its innovative medication delivery system, NPM-119. The FDA has approved Vivani's Investigational New Drug Application (IND) and lifted the clinical hold, allowing the company to initiate its LIBERATE-1™ Phase 1 clinical trial.

Vivani's NPM-119 implant aims to address the common issue of medication non-adherence among type 2 diabetes patients, a problem that affects approximately 50% of this patient group. NPM-119 is designed to provide a long-term therapeutic delivery of exenatide for six months, potentially improving the tolerability issues associated with oral and injectable diabetes medications. This trial marks the first clinical application of Vivani's proprietary NanoPortal™ technology, which facilitates extended drug delivery through subdermal implants.

The LIBERATE-1 study, a 12-week randomized trial, will investigate the safety, tolerability, and pharmacokinetic profile of NPM-119 in type 2 diabetes patients who have previously been treated with GLP-1 therapy. Participants will halt their current GLP-1 treatments before starting either NPM-119 or a weekly exenatide comparator, Bydureon BCise®. The aim is to evaluate how NPM-119's promising preclinical results translate into human applications compared to the existing market options.

Adam Mendelsohn, Ph.D., President and CEO of Vivani, highlighted the importance of this milestone for the company. He emphasized the potential of NPM-119 to address medication non-adherence and improve patient outcomes in type 2 diabetes. Dr. Mendelsohn also noted that the findings from this study would inform further development of Vivani's other lead programs, particularly NPM-115, which targets chronic weight management. NPM-115 has shown weight loss efficacy comparable to semaglutide injections, used in popular products like Ozempic® and Wegovy®, in preclinical studies.

Vivani's NanoPortal™ technology underpins its strategy to enhance medication adherence and patient outcomes by offering a steady and prolonged drug delivery system. This technology aims to overcome the challenges that come with daily or weekly medication regimens, which can lead to poor adherence and suboptimal treatment results. The company is preparing to initiate the LIBERATE-1 trial in the latter half of the year.

In addition to NPM-119, Vivani is developing other drug implants such as NPM-115 for chronic weight management and NPM-139, another potential treatment for weight management with the advantage of a once-yearly dosage. These innovative treatments are part of Vivani's broader pipeline of therapeutic solutions leveraging their NanoPortal™ platform.

Vivani Medical’s subsidiary, Cortigent, is also making strides in the field of neurostimulation systems aimed at helping patients recover essential body functions. Cortigent's projects include Orion®, a device intended to provide artificial vision to the blind, and a new system designed to accelerate recovery for stroke patients with partial paralysis. These advancements highlight Vivani’s commitment to developing groundbreaking medical technologies that address significant healthcare challenges.

Vivani's ongoing efforts to develop and implement long-term, adherence-friendly drug delivery systems hold promise for improving the management of chronic diseases and enhancing patient quality of life. The commencement of the LIBERATE-1 trial represents a crucial step in validating the clinical potential of NPM-119 and the broader application of NanoPortal™ technology.