Business
Vivani Medical Announces FDA Clears Investigational New Drug Application and Lifts Clinical Hold for NPM-119, a Miniature Long-Term Subdermal GLP-1 Drug Implant
NPM-119 is being studied to address medication non-adherence and potentially improve tolerability issues associated with oral and injectable type 2 diabetes
About this update from Vivani Medical, Inc.
[{"type":"text","content":"\nNPM-119 is being studied to address medication non-adherence and potentially improve tolerability issues associated with oral and injectable type 2 diabetes medications, by providing long-term therapeutic delivery of exenatide for six months\n\n\nStudy will represent first clinical application of NanoPortal™, the company’s proprietary, implant platform technology\n\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nVivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative, biopharmaceutical company developing novel, long-term drug implants, today announced the U.S. Food and Drug Administration has cleared the Investigational New Drug Application (“IND”) and lifted the clinical hold on NPM-119 to allow initiation of LIBERATE-1™, a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the Company’s miniature, six-month GLP-1 implant in development for the treatment of type 2 diabetes.\n\n\n“Today marks a significant milestone for Vivani as we transition to a clinical-stage company with a promising drug candidate that has the potential to address medication non-adherence, which affects approximately 50% of patients with type 2 diabetes. LIBERATE-1 represents our first-in-human study of NPM-119 in type 2 diabetes patients, as well as the first clinical application of our innovative NanoPortal™ implant technology in humans,” said Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer. “This seminal work will characterize how NPM-119’s promising preclinical pharmacokinetic profile translates to humans versus the marketed once-weekly exenatide active comparator, Bydureon BCise®.”\n\n\nDr. Mendelsohn added: “The results of the study will also apply to our lead program, NPM-115, which is under development for chronic weight management and demonstrated weight loss comparable to injections of semaglutide, the active ingredient in blockbuster products Ozempic® and Wegovy®, in preclinical studies earlier this year. Subject to regulatory approval, we believe that NPM-115’s six-month dosage form will make it an attractive and highly differentiated option within the extraordinarily large and rapidly growing obesity market. We are focused on final study preparations and anticipate initiating LIBERATE-1 during the second half of the year.”\n\n\nLIBERATE-1 is a randomized, ...