Exenatide

ALAMEDA, Calif.--( BUSINESS WIRE )--Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative biopharmaceutical company developing novel, ultra long-acting drug implants, today announced that screening and enrollment of the first-in-human clinical trial, known as LIBERATE-1™, has been initiated at two centers in Australia to investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant. This study is the first clinical application of the Company’s proprietary NanoPortal™ drug implant technology. “Transitioning to a clinical stage biopharmaceutical company is a major milestone for our company and allows us to determine if the very encouraging results from our animal studies will translate to overweight or obese study subjects,” said Vivani’s President and Chief Executive Officer Adam Mendelsohn, Ph.D. “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, but with the significant benefit of twice-yearly administration.” Dr. Mendelsohn added: “Our emerging portfolio of miniature, ultra long-acting, GLP-1 implants has the potential to be highly differentiated from the injectable and oral products currently on the market and in development. Our proprietary NanoPortal platform technology allows us to develop drug implants 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 provide the convenience of twice-yearly dosing.” LIBERATE-1 is 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 titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani’s exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for a 9-week treatment duration. Changes in weight will be measured. The Company anticipates that top-line data will be available in mid-2025. If available, Vivani intends to utilize research and development incentives and rebates from the Australian government in order to defray a portion of the costs from this clinical trial. Since clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines, data generated in Australia generally are acceptable to the U.S. Food and Drug Administration and other regulatory authorities. Vivani anticipates use of relevant clinical data generated in Australia to support regulatory submissions in other geographies including the United States. Additional guidance regarding future regulatory submissions will be provided as new information becomes available. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, providing convenience, and potentially improving patient tolerance to their medication. Vivani’s lead program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals. Vivani’s emerging pipeline also includes NPM-139 (semaglutide implant) which is also under development for chronic weight management in obese and overweight individuals. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company’s type 2 diabetes development program utilizing a six-month, subdermal exenatide implant. Both the NPM-115 and NPM-119 programs utilize exenatide-based products with a higher-dose associated with the NPM-115 program for chronic weight management in obese or overweight patients. These NanoPortal 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 obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments face significant challenges in achieving positive real-world effectiveness. Vivani remains confident that its portfolio of miniature ultra long-acting GLP-1 implants is highly differentiated from the many obesity products currently in development and has the potential to provide an attractive therapeutic option for patients, prescribers and payers. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the initiation of the LIBERATE-1 trial and reporting of trial results, Vivani’s emerging development plans for NPM-115, NPM-139, NPM-119, and its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani’s products, including NPM-115, NPM-139, and NPM-119; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities, including Vivani’s ability to commence clinical development of NPM-115; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical trials and the results therefrom; Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission filed on March 26, 2024, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.

SAN DIEGO — As researchers explore more potential benefits of GLP-1 medicines, a new retrospective study is suggesting the drug class’ potential to treat venous thromboembolisms, or blood clots in the veins, for individuals with type 2 diabetes. The researchers looked at electronic health records from hundreds of thousands of diabetes patients and compared those who took GLP-1s with another diabetes drug class known as DPP-4 inhibitors. The review found that those who were on GLP-1 drugs had a 20% lower risk of developing the clots after one year. That group also had a 22% lower rate of pulmonary embolisms — clots blocking arteries in the lungs — and an 18% lower rate of deep vein thrombosis. Retrospective studies like this one are useful for finding relationships and suggesting avenues for further study, but the evidence is often considered less persuasive than a randomized, placebo-controlled study. The research was published at the American Society of Hematology annual meeting this weekend. DPP-4 inhibitors were chosen as a control group because they are a commonly used diabetes drug and have no known effect on venous thromboembolisms, lead author Cho Han Chiang told Endpoints News . The research also didn’t separate results by specific GLP-1 drugs. All previously approved drugs were included in the analysis, including newer ones like semaglutide (Novo’s Ozempic and Wegovy) and tirzepatide (Eli Lilly’s Mounjaro and Zepbound), as well as GLP-1s approved in the mid-2000s like exenatide (Lilly’s Byetta). Chiang also included patients who were taking other diabetes drugs like metformin or insulin. The results add to a quickly growing body of evidence that GLP-1 drugs could have broad applications beyond the diabetes and obesity indications that make up the bulk of the market for the drugs. In March, the FDA approved Wegovy to treat cardiovascular disease, and other data have shown potential effects in conditions ranging from liver disease to Parkinson’s and depression. Chiang, a resident at Beth Israel Deaconess Medical Center in Boston, said diabetes and obesity are significant risk factors for venous thromboembolism, one of the reasons he decided to conduct the analysis. There aren’t many medical interventions that can prevent them, he said. “There are some recommendations on the use of low molecular weight heparin and compression stockings,” Chiang said. “But in terms of medical therapy to reduce one of the major risk factors, such as obesity, in contributing to VTE, there’s pretty limited data.” The CDC estimates that there are as many as 900,000 yearly cases of venous thromboembolisms in the US. The next step in Chiang’s research will be to look at conducting a similar analysis specifically for obesity, he said. Other areas where venous thromboembolisms can manifest are some hematological cancers. But whether biopharma companies opt to conduct clinical trials is up to their discretion, he said. “You probably can randomize patients on GLP-1 receptor agonists, and those without, as an add-on therapy to a diabetes regimen” in patients at high risk for developing venous thromboembolisms, Chiang said.