Following the recent regulatory approval, Vivani Medical, Inc. (NASDAQ: VANI) has experienced a notable increase in its stock value during the current market session. At the latest observation, VANI shares surged by 13.15%, reaching $1.85 on the US stock charts.
FDA Approval And Initialization Of Clinical Trial
The FDA has approved the Investigational New Drug Application (IND) and removed the clinical hold on NPM-119, according to a statement from Vivani Medical. Vivani is developing NPM-119, a revolutionary six-month GLP-1 implant, to treat type 2 diabetes.
With this approval, the Phase 1 clinical research LIBERATE-1, aimed at evaluating the pharmacokinetics, safety, and tolerability of NPM-119, may now start. With a treatment candidate that shows promise in treating medication non-adherence—a issue that affects almost half of all type 2 diabetics—the approval is a significant step forward for Vivani Medical.
LIBERATE-1: Pioneering Clinical Study
LIBERATE-1 is Vivani Medical’s first-in-human study of NPM-119 for type 2 diabetes patients and marks the initial clinical application of its groundbreaking NanoPortal implant technology. This pivotal trial will assess how the preclinical pharmacokinetic profile of NPM-119 translates to human subjects in comparison to the marketed exenatide once-weekly active comparator, Bydureon BCise.
The outcomes of LIBERATE-1 will also impact Vivani Medical’s leading program, NPM-115, which is being developed for chronic weight management. Preclinical studies earlier this year demonstrated that NPM-115 could achieve weight loss comparable to semaglutide injections, the active ingredient in popular products such as Ozempic and Wegovy.
Subject to regulatory approval, the six-month dosage form of NPM-115 is poised to be a highly differentiated and appealing option in the rapidly expanding obesity market. Vivani Medical is finalizing study preparations and expects to initiate LIBERATE-1 in the latter half of the year.
Advancing Innovative Drug Implants
LIBERATE-1 is a randomized, 12-week investigation designed to assess the safety, tolerability, and comprehensive pharmacokinetic profile of NPM-119 in patients with type 2 diabetes. The trial will include patients who have previously undergone GLP-1 therapy, which will be discontinued before starting treatment with either NPM-119 or the active comparator.
