Vivani Medical To Perform Clinical Study For Miniature

Medical, Inc, an innovative biopharmaceutical business developing unique, long-term medication implants, said that the first clinical study in the NPM-115 program is expected to begin in Australia in the fourth quarter of 2024, subject to regulatory clearance. The NPM-115 clinical trial will assess an investigational 6-month GLP-1 implant for chronic weight management in patients who are obese or overweight and have an associated comorbidity.

On February 28, 2024, Vivani declared positive preclinical weight loss data from its exenatide implant as part of its NPM-115 development program, which were comparable to semaglutide injections (the active pharmaceutical ingredient in Ozempic/Wegovy), as well as a strategic shift to prioritize its obesity portfolio. Vivani stated on June 13, 2024, that the US Food and Drug Administration (FDA) had cleared its Investigational New Drug application for its exenatide implant, which would be examined in patients with type 2 diabetes as part of the NPM-119 development program. 

“In February, our company announced that we were re-prioritizing the development of our GLP-1 implants to focus on the treatment of obesity and chronic weight management in response to the significant medical need and unprecedented market demand,” said Adam Mendelsohn, Ph.D., Vivani’s president and chief executive officer. “Today we can report that our first-in-human study, LIBERATE-1, is expected to enroll patients who are obese or overweight to primarily support NPM-115’s development programme. We anticipate initiating this clinical study in Australia later this year."