Vivani Medical Announces Positive NPM-115 Preclinical Weight Loss Data Comparable to Ozempic/Wegovy and Discloses NPM-139 as Semaglutide as Strategy Shifts to Prioritize Obesity Portfolio - Seite 3

Dr. Mendelsohn will present study results on May 17 at the TIDES USA 2024 conference in Boston.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal platform, Vivani Medical develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve medication tolerability. Vivani’s NPM-115 and NPM-119 are miniature, six-month, GLP-1 implants in development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. Both NPM-115 and NPM-119 are exenatide based products with a higher-dose associated with NPM-115 for the treatment of chronic weight management in obese or overweight patients. An IND for NPM-119’s first-in-human study LIBERATE-1 has been submitted and is on clinical hold pending requests by the FDA for additional chemistry, manufacturing, and controls (CMC) information. Vivani anticipates submitting the requested CMC information to the FDA in the first half of 2024. LIBERATE-1 is a randomized, 12-week investigation of the safety, tolerability, and full pharmacokinetic profile of NPM-119 in patients with type 2 diabetes. Vivani is also preparing to submit an IND for a first-in-human study with NPM-115 for the treatment of chronic weight management later this year. These NanoPortal^TM implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why obese or overweight patients, and patients taking type 2 diabetes or other chronic disease medications face significant challenges in achieving positive real-world effectiveness.