Vivani Medical, Inc. (Nasdaq: VANI), a pioneer in biopharmaceutical innovations, has reached a pivotal milestone as the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for NPM-119, marking a significant advancement in the treatment of type 2 diabetes. This approval also lifts a previous clinical hold, allowing the initiation of the LIBERATE-1 Phase 1 clinical trial aimed at evaluating the safety, tolerability, and pharmacokinetics of NPM-119, a promising six-month GLP-1 implant.

Groundbreaking Progress in Diabetes Management

The clearance of the IND by the FDA is not just a procedural step; it represents a transformative leap towards addressing the widespread issue of medication non-adherence among type 2 diabetes patients. Approximately 50% of such patients struggle with adherence, a challenge that Vivani Medical aims to overcome with its innovative NanoPortal implant technology.

Adam Mendelsohn, Ph.D., President and Chief Executive Officer of Vivani Medical, emphasized the significance of this development: “Today marks a significant milestone for Vivani as we transition to a clinical-stage company with a promising drug candidate. LIBERATE-1 represents our first-in-human study of NPM-119 in type 2 diabetes patients, as well as the first clinical application of our innovative NanoPortal implant technology in humans.”

Clinical Trial and Broader Implications

LIBERATE-1 is set to be a randomized, 12-week trial focusing on the comprehensive pharmacokinetic profile of NPM-119 compared to the marketed once-weekly exenatide active comparator, Bydureon BCise®. This trial is crucial in translating the promising preclinical pharmacokinetic profile of NPM-119 to real-world applications in human subjects.

Dr. Mendelsohn further added insights into the broader potential of their research: “The results of the study will also apply to our lead program, NPM-115, which is under development for chronic weight management and demonstrated weight loss comparable to injections of semaglutide, the active ingredient in blockbuster products Ozempic and Wegovy, in preclinical studies earlier this year.”

Expanding Portfolio and Future Prospects

In addition to NPM-119, Vivani Medical is advancing the development of NPM-115 for chronic weight management and NPM-139 for semaglutide implant, with the latter having potential for a once-yearly treatment duration. These developments underscore Vivani’s commitment to leveraging its proprietary NanoPortal™ technology to ensure medication adherence and enhance patient outcomes in chronic disease management.

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