The company anticipates a fourth-quarter start for its NPM-115 program in Australia, pending regulatory clearance there. This program looks at the investigational six-month GLP-1 implant for chronic weight management. The company intends to evaluate patients who are either obese or overweight with a related comorbidity.
Vivani recently received the green light from the FDA to begin a separate clinical program for NPM-119, a six-month GLP-1 implant for treating type 2 diabetes. That now-approved trial also applies to NPM-115.
Both implants utilize the company’s NanoPortal implant technology to steadily deliver medication over extended periods of time. The company aims to guarantee correct doses for patients while avoiding potential safety concerns around fluctuating drug release profiles. The technology can also deliver large hydrophilic molecules, including peptides and proteins. The company believes this enables a broader range of therapeutic applications.
Vivani’s latest milestone follows a strategic shift announced earlier this year aimed at prioritizing obesity implants. The company said it based this change on emerging data regarding the potential for high-dose GLP-1 products.
“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, Vivani president and CEO. “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 program. We anticipate initiating this clinical study in Australia later this year.”
Mendelsohn also said the company believes the results of the trial “may provide clinical validation of our NanoPortal drug delivery technology to support a broader application of the technology in the treatment of chronic diseases.”
