As GLP-1 receptor agonist injections continue to gain acceptance as effective solutions for weight management and cardiovascular health, a tiny drug-delivering implant from Vivani Medical is in development and could rival current options. Vivani released positive preclinical results from its miniature, twice-yearly exenatide implant, known as NPM-115, for weight management. The company also reported that its miniature once-yearly implant, NPM-139, uses semaglutide as its active pharmaceutical ingredient. In addition, Vivani is developing NPM-119, an exenatide implant to treat Type 2 diabetes.
Implant Innovation
NPM-115 is a subdermal implant that delivers continuous dosing of exenatide, a GLP-1 receptor agonist. This delivery system, facilitated by Vivani’s NanoPortal™ platform, ensures sustained medication adherence over six months and potentially improves treatment tolerability. “The potential for improvement in medication adherence, tolerability and real-world patient outcomes motivates us to rapidly advance the development of NPM-115, NPM-139 and the balance of our portfolio,” said Adam Mendelsohn, Vivani’s CEO, in a press release. Exenatide medications are currently available as twice-daily and weekly injections.
Compelling Preclinical Data
Recent studies in mice have highlighted the effectiveness of Vivani’s exenatide implant in inducing weight loss in non-diabetic animals. After being fed a high-fat diet to induce obesity, mice that received the NPM-115 implant reduced their body weight by nearly 20 percent within 28 days. Obese mice that received high-dose semaglutide injections showed similar results.
A second study showed that NPM-119 stimulated significant weight loss in healthy rats. The animals that received the implant had about 25 percent lower body weights at 15 weeks post-implantation compared with rats with a control group. For this study, the animals received exenatide at a lower dose (around 320 nmol/kg/day compared to 530 nmol/kg/day in the NPM-115 study).
Strategic Shift: From Diabetes to Obesity
Mendelsohn acknowledges the company’s strategic shift from focusing primarily on Type 2 diabetes to prioritizing obesity treatment. “In response to tremendous medical need and unprecedented market demand, we are prioritizing the development of our GLP-1 implants for the treatment of obesity and chronic weight management,” he said. “Since a high-dose GLP-1 implant for obesity would likely also be able to address our previous Type 2 diabetes focus, the recently generated compelling weight loss data from NPM-115 naturally supports a shift in focus towards an indication with even broader potential.”
Innovative Drug Delivery
Central to Vivani’s strategy is its NanoPortal device, a miniature titanium cylinder equipped with a drug reservoir and nanotubes for controlled medication release. The device is implanted under the skin and replaced after six months or, in the case of NPM-139, after one year. Drug-secreting implants are a promising option for delivering GLP-1 therapies for weight loss, as less frequent dosing has been found to enhance adherence.
Regulatory Considerations
If Vivani obtains FDA approval for its GLP-1 implants, it will be the first company to do so. Intarcia Therapeutics was denied FDA approval for its six-month diabetes drug implant due to safety concerns around dosing stability. Vivani’s implant is unique because of its non-viscous formulation and absence of a moving piston. This results in a smooth and steady release. Although the mouse study’s duration wasn’t long enough to directly measure the outcomes that the FDA was concerned about, Mendelsohn contends that the implant’s minimally fluctuating release profile could maintain steady dosing and prevent the release of unsafe drug levels.
Adding to Weight Management Options
In conclusion, Vivani’s miniature exenatide implant may represent a novel option in weight management medications, in addition to the currently available injectable and oral formulations, potentially offering a potent and innovative solution to address the growing global burden of obesity.
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