FDA Clears Vivani Medical’s IND and Lifts Clinical Hold for NPM-119

DENVER, Colo., Jun 13, 2024 (247marketnews.com)- Vivani Medical, Inc. (Nasdaq:VANI) stated that the U.S. Food and Drug Administration 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).

Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer, commented, “Today marks a significant milestone for Vivani as we transition to a clinical-stage company with a promising drug candidate that has the potential to address medication non-adherence, which affects approximately 50% of patients with type 2 diabetes. 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.

“This seminal work will characterize how NPM-119’s promising preclinical pharmacokinetic profile translates to humans versus the marketed once-weekly exenatide active comparator, Bydureon BCise.

“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. Subject to regulatory approval, we believe that NPM-115’s six-month dosage form will make it an attractive and highly differentiated option within the extraordinarily large and rapidly growing obesity market. We are focused on final study preparations and anticipate initiating LIBERATE-1 during the second half of the year.”

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