FDA Approves Vivani Medical's NPM-119 GLP-1 Subdermal Implant and Lifts Clinical Hold

Vivani Medical, Inc., a pioneering biopharmaceutical company focused on creating new, extended-release drug implants, declared that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug Application and removed the clinical hold on NPM-119. This clearance permits the commencement of LIBERATE-1™, a Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of NPM-119 (exenatide). The product is the Company’s compact, six-month GLP-1 implant being developed for the treatment of type 2 diabetes.

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"Vivani is reaching an important milestone as we evolve into a clinical-stage enterprise with a drug candidate that shows promise in addressing the issue of medication non-adherence, which impacts nearly 50% of individuals with type 2 diabetes. LIBERATE-1 stands as our inaugural human study of NPM-119 for type 2 diabetes patients and marks the initial clinical trial utilizing our pioneering NanoPortal™ implant technology in human subjects," stated Adam Mendelsohn, Ph.D., President and CEO of Vivani.

"This groundbreaking research aims to assess how the encouraging preclinical pharmacokinetic profile of NPM-119 compares in humans against the currently available once-weekly exenatide, Bydureon BCise," added Adam Mendelsohn. 

LIBERATE-1 is a 12-week, randomized study that will examine the safety, tolerability, and comprehensive pharmacokinetic profile of NPM-119 in type 2 diabetes patients. Participants who had previously received GLP-1 therapy, which will be discontinued, will be enrolled and assigned either NPM-119 or the active comparator. 

Vivani is continuing to advance its innovative, differentiated drug implants pipeline, utilizing its proprietary NanoPortal™ subdermal implant technology aimed at ensuring medication adherence and enhancing patient outcomes in the management of chronic diseases like chronic weight management and type 2 diabetes.

Beyond NPM-119 for type 2 diabetes, Vivani is also progressing in the development of NPM-115 (a high-dose exenatide implant) and NPM-139 (a semaglutide implant), both of which are prospective treatments for chronic weight management. Additionally, NPM-139 presents the possibility of an annual treatment regimen."

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According to the data provided by the Synapse Database, As of June 14, 2024, there are 380 investigational drugs for the GLP-1R targets, including 104 indications, 321 R&D institutions involved, with related clinical trials reaching 2735, and as many as 9976 patents.

Exenatide is a synthetic peptide drug developed by Nano Precision Medical, Inc. that targets the GLP-1R. As a pharmaceutical organization specializing in biomedicine, Nano Precision Medical, Inc. has been at the forefront of developing innovative pharmaceutical products in this field.