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Vivani Medical Receives Regulatory Approval to Initiate First in Human Clinical Trial with GLP-1 Implant in Obese and Overweight Individuals in Australia
NPM-115 clinical program utilizes a miniature, GLP-1 (exenatide) implant designed to provide comparable efficacy to semaglutide, the active ingredient in
About this update from Vivani Medical, Inc.
[{"type":"text","content":"\nNPM-115 clinical program utilizes a miniature, GLP-1 (exenatide) implant designed to provide comparable efficacy to semaglutide, the active ingredient in Ozempic®/Wegovy®, with twice-yearly administration\n\nStudy will represent the first clinical application of NanoPortal™, the Company’s proprietary drug implant platform technology\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nVivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative, biopharmaceutical company developing novel, ultra long-acting drug implants, today announced that the Bellberry Human Research Ethics Committee (“HREC”) has approved and the Therapeutic Goods Administration (“TGA”) in Australia has formally acknowledged a first in human clinical trial of the Company’s miniature, subdermal GLP-1 (exenatide) implant in obese and overweight subjects. This clinical trial, known as LIBERATE-1™, will investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant and represents the first clinical application of the Company’s proprietary NanoPortal™ drug implant technology.\n\n“Securing regulatory approval keeps us on schedule to initiate this trial in Australia in the fourth quarter of 2024,” said Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer. “Preclinical weight loss and liver fat data announced earlier this year supports the potential for our GLP-1 implant to provide comparable efficacy to semaglutide, the active ingredient in blockbuster products Ozempic® and Wegovy®, but with the significant benefit of twice-yearly administration. We remain confident that our emerging portfolio of miniature, ultra long-acting, GLP-1 implants has the potential to be highly differentiated from the injectable and oral products in the market and in development. Specifically, our implants are uniquely designed to address medication non-adherence, a critical challenge for many patients which we believe represents the largest opportunity to improve real world health outcomes for patients, and the steady delivery of medicine enabled by our NanoPortal technology may also improve treatment tolerability.”\n\nLIBERATE-1 will be a randomized investigation of the safety, tolerability and pharmacokinetic profile of the exenatide NanoPortal implant in obese or overweight subjects. The trial will enroll participants who will be ti...