Vivani Medical Announces Publication of Positive Weight Loss Data Supporting Potential Veterinary Use of OKV-119 Miniature, Long-term GLP-1 Implant
Vivani Medical (Nasdaq: VANI) announced positive data on its OKV-119 exenatide implant for feline weight loss, published in BMC Veterinary Research. The study highlights that a single OKV-119 implant delivers exenatide over 3 months, leading to significant weight loss in cats. This reinforces the potential of Vivani's NanoPortal™ technology for addressing obesity in both humans and animals. Vivani's development partner, Okava Pharmaceuticals, is exploring the use of OKV-119 for pre-diabetes, diabetes, and obesity in companion felines. The promising results support further clinical evaluations of the implant for chronic weight management in humans.
- Positive weight loss data published in BMC Veterinary Research.
- OKV-119 implant delivers exenatide effectively for 3 months.
- Significant weight loss in cats observed.
- Potential for Vivani's NanoPortal™ technology to treat obesity in humans.
- Development partner Okava Pharmaceuticals exploring OKV-119 for feline pre-diabetes, diabetes, and obesity.
- Supports further clinical evaluations for chronic weight management in humans.
- The study results are based on pre-clinical animal models, not human trials.
- The duration of drug delivery in humans still needs validation.
- Potential challenges in scaling the technology from felines to humans.
Insights
Vivani Medical's recent publication on the OKV-119 implant sheds light on a potential breakthrough in managing feline obesity, a significant concern for nearly
From a market perspective, Vivani's focus on the veterinary sector is strategic. Pet care and veterinary services represent a multi-billion dollar industry and obesity management in pets could be a high-growth segment. If OKV-119 proves successful, it could capture a substantial market share, offering a new revenue stream for Vivani. Further, the successful application in cats could serve as a proof-of-concept for broader, more lucrative human applications, amplifying its market potential. However, it's worth noting that regulatory hurdles and the need for further long-term data could delay market entry and acceptance.
For retail investors, the key takeaway is that Vivani is diversifying its portfolio with innovative solutions that tap into both veterinary and human health sectors. While the short-term impact on stock might be limited due to ongoing studies, the long-term outlook appears promising if subsequent trials confirm these initial results.
From a financial standpoint, Vivani Medical's positive data on their OKV-119 implant could potentially boost investor confidence, particularly given the proprietary NanoPortal™ platform's promising results in long-term drug delivery. The publication is a important step in validating the efficacy of their technology in a real-world setting.
However, the financial landscape for Vivani hinges on several factors. The licensing agreement with Okava Pharmaceuticals for veterinary applications could provide an immediate source of revenue through royalties. Yet, the substantial financial upside lies in successfully adapting this technology for human applications, specifically for obesity and type 2 diabetes management. Retail investors should monitor upcoming clinical trials closely, as positive human trials could significantly increase the company's valuation.
Consideration should also be given to the potential costs and regulatory challenges involved in extending this technology to human use. Investors should weigh the risks of delayed approvals and additional funding requirements against the promising initial data.
Data Published in BMC Veterinary Research shows that OKV-119 exenatide implant reduced feline weight
Felines share many pathophysiologic obesity phenotypes with humans, further supporting clinical evaluations of miniature, subdermal GLP-1 implants for obesity reduction
Development partner, Okava Pharmaceuticals, is studying OKV-119 for the treatment of pre-diabetes, diabetes, and obesity in companion felines
“The data published in BMC Veterinary Research is further evidence that our proprietary NanoPortal implant technology holds promise in reducing obesity in cats,” said Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer. “Felines share many pathophysiologic obesity phenotypes with humans, and our pre-clinical studies of NPM-115 and NPM-119 in other animal models, in addition to this cat data, support our efforts to clinically evaluate our miniature, subdermal GLP-1 implants for the treatment of chronic weight management in obese or overweight human patients and type 2 diabetes, respectively. Vivani is dedicated to rapidly developing our portfolio of weight loss focused implants as they collectively have the potential to improve medication adherence, tolerability and real-world patient results.”
Researchers estimate that up to
The study evaluated the drug release characteristics of subcutaneous OKV-119 implants configured to release exenatide for 84 days. Key findings include:
- Long-Term Delivery: A single OKV-119 implant effectively delivered exenatide for the 3-month duration for which this configuration was designed to last
- Weight Loss: Exposure to exenatide plasma concentrations ranging from 1.5 ng/ml to 4 ng/ml induced weight loss in cats
- Health Impact: Obesity in cats, like in humans, is associated with decreased life expectancy and various health complications
Vivani has separately demonstrated the delivery of exenatide over a 6-month duration both in vitro and in vivo (in a rat) and anticipates extending the duration of OKV-119 to 6 months for future studies. To access the full article, visit: https://bmcvetres.biomedcentral.com/articles/10.1186/s12917-024-04051-6.
About OKV-119
OKV-119 is a miniature, subdermal, exenatide drug implant designed to treat the growing number of clinically obese cats and feline diabetes. This device can be conveniently inserted under the skin during routine veterinary visits and is being designed to provide steady doses of medication for up to six months.
OKV-119 is being developed under a partnership with Vivani Medical, Inc.
About OKAVA Pharmaceuticals, Inc.
OKAVA is a clinical-stage research and development company that develops new treatment options for dogs and cats suffering from chronic diseases of aging. OKAVA is building a portfolio of products to transform and humanize standards of care in veterinary medicine. By harnessing human technologies for the treatment of common diseases in household pets, the company has the potential of increasing the lifespans of dogs and cats by an average of 1 to 3 years. OKAVA is a private company headquartered in
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal™ platform, Vivani Medical develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve medication tolerability. Vivani’s lead programs NPM-115 and NPM-119 are miniature, six-month, GLP-1 implants in development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. Both NPM-115 and NPM-119 are exenatide based products with a higher-dose associated with NPM-115 for the treatment of 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
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 our business, product candidates, including the therapeutic potential thereof and the planned development therefore, technology and strategy. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our 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 our 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 our product candidates, including NPM-115, NPM-119, and OKV-119; delays and changes in applicable laws, regulations and guidelines including potential delays in submitting required regulatory applications to the
View source version on businesswire.com: https://www.businesswire.com/news/home/20240528848430/en/
Company Contact:
Donald Dwyer
Chief Business Officer
info@vivani.com
(818) 833-5000
Investor Relations Contact:
Brigid Makes
Chief Financial Officer
investors@vivani.com
(818) 833-5000
Media Contact:
Sean Leous
ICR Westwicke
Sean.Leous@westwicke.com
(646) 866-4012
Source: Vivani Medical, Inc.
FAQ
What positive data did Vivani Medical announce regarding OKV-119?
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