EXCLUSIVE: Vivani Medical's Type 2 Diabetes Treatment NPM-119 Subdermal Implant's IND Gains FDA Clearance For Clinical Use (UPDATED)

Vivani Medical, Inc. VANI announced that the U.S. FDA has cleared its Investigational New Drug Application for NPM-119, paving the way for the commencement of the LIBERATE-1 Phase 1 trial.

This study will assess the safety, tolerability, and pharmacokinetics of Vivani’s innovative six-month GLP-1 implant, designed to treat type 2 diabetes.

LIBERATE-1 is a 12-week randomized trial designed to evaluate the safety, tolerability, and pharmacokinetics of NPM-119 in patients with type 2 diabetes.

Participants in this study will discontinue their existing GLP-1 therapy to either receive NPM-119 or a comparator drug. VANI anticipates launching LIBERATE-1 in the second half of the year.

Vivani is advancing its portfolio of unique drug implants using its NanoPortal technology. These implants aim to improve medication adherence and outcomes in chronic diseases like type 2 diabetes and chronic weight management.

“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,” commented Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer.

“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®,” Mendelsohn added.

Additionally, Vivani is developing NPM-115 (high-dose exenatide implant) and NPM-139 (semaglutide implant), both targeting chronic weight management, with NPM-139 potentially offering annual dosing.

Dr. Mendelsohn stated that the findings from the study would also benefit their main project, NPM-115, aimed at chronic weight management. Earlier this year, preclinical studies showed NPM-115’s weight loss effects were comparable to semaglutide injections used in Ozempic and Wegovy.

Pending regulatory approval, he highlighted the potential of NPM-115’s six-month dosage to stand out in the growing obesity market.

Price Action: VANI shares are trading lower by 1.84% at $1.60 premarket at the last check Thursday.