Vivani Medical Announces Initiation of First in Human Clinical Trial with GLP-1 Implant in Obese and Overweight Individuals in Australia

Rhea-AI Summary

Vivani Medical (NASDAQ: VANI) has initiated its first-in-human clinical trial, LIBERATE-1™, testing a novel GLP-1 (exenatide) implant for obesity and overweight treatment at two Australian centers. The trial marks the first clinical application of their proprietary NanoPortal™ drug implant technology, designed to provide comparable efficacy to semaglutide with twice-yearly administration.

The randomized trial will evaluate safety, tolerability, and pharmacokinetics in participants who will first undergo 8 weeks of semaglutide titration before being randomized into three groups: exenatide implant (n=8), weekly exenatide injections (n=8), or weekly semaglutide injections (n=8) for 9 weeks. Top-line data is expected in mid-2025.

Positive

• First clinical trial initiated for GLP-1 implant technology
• Potential for twice-yearly administration versus weekly injections
• Clinical data from Australian trials can support US FDA submissions
• Eligible for Australian government research incentives and rebates

Negative

• Top-line data not available until mid-2025
• Small trial size with only 24 total participants
• Efficacy compared to semaglutide still unproven in humans

Insights

Clinical Research Analyst

The initiation of LIBERATE-1™, Vivani's first-in-human trial for their GLP-1 implant, marks a pivotal development in the competitive obesity treatment landscape. The study's design is particularly noteworthy - comparing their twice-yearly exenatide implant against both weekly exenatide and semaglutide injections provides direct competitive positioning data. The 24 participant study incorporates a smart titration phase, essential for managing GLP-1 side effects.

The selection of Australia for the trial is strategically sound, offering both R&D incentives and FDA-acceptable data generation. The mid-2025 timeline for topline data suggests careful attention to long-term safety monitoring. The NanoPortal™ technology, if successful, could address the critical adherence challenges seen with current GLP-1 treatments, where missed doses significantly impact efficacy.

Market Research Analyst

Vivani's entry into the $100+ billion GLP-1 market with a novel implant delivery system represents a potentially disruptive innovation. Current market leaders like Novo Nordisk and Eli Lilly rely on weekly or daily administrations - a twice-yearly implant could capture significant market share, particularly among patients struggling with injection fatigue or adherence issues. For a company with a modest $71.5M market cap, successful trial outcomes could trigger substantial valuation rerating.

The timing aligns well with growing market acceptance of GLP-1 therapies, though competitive dynamics will likely intensify by 2025. The Australian trial strategy demonstrates prudent capital management, leveraging research incentives while maintaining FDA-relevant data quality.

Biotech Expert

The NanoPortal™ platform technology represents a significant engineering achievement in sustained-release drug delivery. The challenge of maintaining stable exenatide concentrations over six months while preserving bioactivity is substantial. Previous attempts at long-acting GLP-1 implants have struggled with protein stability and consistent release kinetics.

The preclinical data reference suggesting comparable efficacy to semaglutide is particularly intriguing. If translated to humans, this would validate both the delivery technology and the potential for broader application to other peptide therapeutics. The three-arm study design, including both exenatide and semaglutide comparators, demonstrates confidence in their technology's performance.

NPM-115 clinical program utilizes a miniature, GLP-1 (exenatide) implant designed to provide comparable efficacy to semaglutide, with twice-yearly administration

Study represents the first clinical application of NanoPortal™, the Company’s proprietary drug implant platform technology

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241219052547/en/

Company Contact:

Donald Dwyer

Chief Business Officer

info@vivani.com

(415) 506-8462

Investor Relations Contact:

Jami Taylor

Investor Relations Advisor

investors@vivani.com

(415) 506-8462

Media Contact:

Sean Leous

ICR Westwicke

Sean.Leous@westwicke.com

(646) 866-4012

Source: Vivani Medical, Inc.

FAQ

When will Vivani Medical (VANI) release LIBERATE-1 trial results?

Vivani Medical expects to release top-line data from the LIBERATE-1 trial in mid-2025.

How many participants are enrolled in Vivani's LIBERATE-1 GLP-1 implant trial?

The trial will enroll 24 participants divided into three groups of 8 participants each.

What is the dosing frequency of Vivani's GLP-1 implant compared to current treatments?

Vivani's GLP-1 implant is designed for twice-yearly administration, compared to weekly dosing for current injectable treatments.

Where is Vivani Medical conducting its LIBERATE-1 clinical trial?

The LIBERATE-1 trial is being conducted at two centers in Australia.

How long is the treatment duration in Vivani's LIBERATE-1 trial?

The trial includes an 8-week titration period followed by a 9-week treatment duration.