By Sabela Ojea


Vivani Medical said the U.S. Food and Drug Administration has cleared its investigational new drug application, allowing the company to start a phase 1 trial of its potential type 2 diabetes treatment NPM-119.

The developer of long-term drug implants said Thursday that the clearance allows the phase 1 trial will assess the safety, tolerability and pharmacokinetics of NPM-119.

NPM-119 is the company's miniature, six-month GLP-1 receptor implant in development for the treatment of type 2 diabetes.

"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," Chief Executive Adam Mendelsohn said.

Mendelsohn said results of the study will also apply to Vivani's lead program, NPM-115, which is under development for chronic weight management and demonstrated weight loss versus injections of semaglutide, the compound in Novo Nordisk's blockbuster drugs Ozempic and Wegovy.


Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix


(END) Dow Jones Newswires

06-13-24 0857ET