Workflow
Drug Implant Technology
icon
Search documents
Vivani Medical Announces Rapid Advancement of NPM-139, a Novel Semaglutide Implant, Following Positive Weight Loss Data from an Ongoing Preclinical Study of NPM-139 and Promising Results from the LIBERATE-1 Phase 1 Clinical Study of NPM-115
Globenewswireยท 2025-08-05 12:10
Core Insights - Vivani Medical, Inc. has reported positive results from the LIBERATE-1 clinical study, which is the first-in-human application of its NanoPortal implant technology, demonstrating a favorable safety and tolerability profile for the NPM-115 implant [1][3][4] - The company has also presented preclinical feasibility data for the NPM-139 semaglutide implant, indicating approximately 20% weight loss maintained for over 6 months with a single implant, supporting the potential for annual dosing [1][2][3] - Based on these findings, Vivani is prioritizing the advancement of NPM-139, with clinical development expected to commence in 2026, pending regulatory clearance [1][3][11] LIBERATE-1 Study Results - The LIBERATE-1 Phase 1 study successfully met its primary objectives, evaluating the safety and tolerability of the NPM-115 implant and characterizing its pharmacokinetic profile over a 9-week duration [4][5] - The study found that the implant was generally well tolerated, with no serious adverse events reported, and the drug release profile showed promise for durable delivery over a 6-month period [4][5] NPM-139 (Semaglutide Implant) Development - The preclinical study for NPM-139 has shown significant weight loss results, with a single administration leading to weight loss sustained for over 231 days [7][11] - The company believes that the development timelines for NPM-115 and NPM-139 are comparable, and the established success of semaglutide products in the market supports the confidence in NPM-139 [3][12] - Semaglutide-based products, including Ozempic, Wegovy, and Rybelsus, generated over $29 billion in sales in 2024, indicating strong commercial potential for NPM-139 [3][12]