Vivani Medical, Inc. VANI (“Vivani” or the “Company”), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, today reported financial results for the second quarter of 2023 and provided a business update.
Vivani™ continues to advance its emerging portfolio of innovative, highly differentiated drug implants leveraging its proprietary NanoPortal™ subdermal implant technology designed to guarantee medication adherence and improve patient outcomes in the treatment of chronic diseases. Vivani’s lead therapeutic candidate, NPM-119, is a miniature, six-month, GLP-1 implant using NanoPortal technology.
“At Vivani, we are continuing our progression from a preclinical to clinical-stage biopharmaceutical company. As planned, we have successfully completed the production of clinical trial materials and submitted our Investigational New Drug (IND) application for NPM-119 (exenatide implant) in July. Although we received verbal notification from the U.S. Food and Drug Administration (FDA) that our NPM-119 IND will be placed on clinical hold, we await the receipt of FDA’s comments and intend to respond to the agency’s requests with the goal of achieving IND clearance and proceeding with our plans to initiate the proposed first-in-human, Phase 2 clinical study of NPM-119 named LIBERATE-1™,” said Adam Mendelsohn, Ph.D., Vivani’s President and Chief Executive Officer. “LIBERATE-1 represents the first clinical application of our NanoPortal technology and is designed to evaluate the safety, tolerability and full pharmacokinetic profile of NPM-119 compared to an active control group. The study will also evaluate glycemic control and weight-loss information and we aim to better understand the translation of drug release profiles from our animal models to patients with type 2 diabetes which will inform the development of NPM-119 and our emerging portfolio of long-term drug implants with the potential to revolutionize chronic…