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

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

Vivani Medical, Inc. (NASDAQ: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.

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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.

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This article EXCLUSIVE: Vivani Medical's Type 2 Diabetes Treatment NPM-119 Subdermal Implant's IND Gains FDA Clearance For Clinical Use (UPDATED) originally appeared on Benzinga.com

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