Once a year GLP1? Exploring Semaglutide implants

GLP1 implants that are administered once or twice a year and deliver consistent Semaglutide, powered by Vivani Medical's NanoPortal technology.

Once a year GLP1? Exploring Semaglutide implants

Currently most GLP1 treatments (injections, pills) are either taken on a weekly cadence or daily. What if you could take GLP1 once and have the effects last for a full year?

Vivani Medical is working on just that – a GLP1 implant that delivers the medication throughout an entire year (administered possibly once or twice a year):

Vivani Medical Announces Positive Preclinical Weight Loss Data for NPM-139 Semaglutide Implant, with Potential for Once-Yearly Dosing
NanoPortal™ technology successfully delivers semaglutide, the active ingredient in Ozempic®/Wegovy®, in a preclinical study with……

This is quite the interesting new direction (and one most people probably wouldn't have expected), so we took a closer look.

What does Vivani Medical do?

Vivani is a publically traded company that specializes in drug delivery (via medical implants). They produced a technology caled NanoPortal which aims to enable constant delivery of medication.

Investors
Vivani Medical is an emerging biopharmaceutical company developing a pipeline of miniature, long-term drug implants with its proprietary NanoPortal™ platform technology for obesity/weight management and other chronic diseases. Vivani’s lead…

They state it quite clearly on their Investors page:

Vivani Medical is an emerging biopharmaceutical company developing a pipeline of miniature, long-term drug implants with its proprietary NanoPortal™ platform technology for obesity/weight management and other chronic diseases.

Right now they seem to be wholly focused on obesity drugs, but this technology isn't solely applicable there. Clearly, NanoPortal is a great fit for obesity medication like GLP1s, which require weekly or daily dosing and can be easy to forget to administer.

While very promising, Vivani is that they're still quite a new company – they have not produced any clinical trials that prove their approach to be effective and safe just yet, and they are a ways from being anywhere near purchasable or approved by regulatory bodies.

What is NPM-139?

NPM-139 is an application of Vivani's drug delivery technology (NanoPortal) to Semaglutide for use in treating obesity.

With NPM-139, patients can receive implants once or twice a year that deliver Semaglutide (the active GLP1 Receptor Agonist in Ozempic, Wegovy, and Rybelsus) for an extended period of time.

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Don't know what a GLP1 Receptor Agonist is, or how drugs like Ozempic, Mounjaro, Wegovy, or Zepbound work?

Check out our quick explainer

What stage of research is NPM-139 in?

NPM 139 is just one of the drugs that Vivani is developing – their pipeline has a few others:

While we can mostly ignore the "market size" indicator there (that's a bit more important for investors than patients), NPM 139 is actually the latest drug in their pipeline – which means it's the furthest from production.

This means that unfortunately we won't be able to get high quality data about NPM -139 for quite a while, but NPM-115 is an important test of NanoPortal, Vivani's flagship technology.

LIBERATE-1, a clinical study of NanoPortal + Exenatide which promises to shed light on NPM-139

Vivani Medical announced positive pre-clinical results for NPM-139 recently:

Vivani Medical Announces Positive Preclinical Weight Loss Data for NPM-139 Semaglutide Implant, with Potential for Once-Yearly Dosing
NanoPortal™ technology successfully delivers semaglutide, the active ingredient in Ozempic®/Wegovy®, in a preclinical study with……

Data for the study is not fully available yet, but is likely to be released by mid-2025:

The ongoing NPM-115 clinical study, LIBERATE-1, for which the first successful implantation was recently announced, remains on track to produce top-line data by mid-2025

You might be thinking that this conflicts with the information on the stage of NPM-139 in the pipeline shared earlier, and therein lies the rub:

While LIBERATE-1 will primarily inform continued development of NPM-115, LIBERATE-1 will also provide critical information to support the development of NPM-139 and other pipeline programs since it represents the first human application of the NanoPortal technology.

Exenatide is at this point considered inferior in many ways to more recent GLP1s (Semaglutide, Tirzepatide, etc), and the ongoing study is primarily for the exenatide variant that Vinani is offering.

The study is important mostly because it will be a test of NanoPortal, Vivani's technology – rather than the combination of Nanoportal and Semaglutide, and given the similarities between Exenatide and Semaglutide, there are likely to be inferences that can be safely made.

Unfortunately, the study is relatively small, 24 people in total which will be split between NanoPortal, Exenatide and Semaglutide. The study is also administered only in one country, Australia.

Are there any additional downsides to NPM 139?

Unfortunately, at this stage it is hard to tell whether there will be additional downsides to NPM-139.

The data from NPM-115's study (LIBERATE-1) hasn't been completely released yet, and 8 people is just not enough to draw any meaningful conclusions from.

There is a lack of clinical research and studies on both NovoPortal (Vivani's drug delivery mechanism), and the effects of delivering Semaglutide dosages via an implant rather than via a pill or subcutaneous injection. At the very least, we'll get clarity on NovoPortal by mid-2025.

We're likely going to be waiting at least 2-4 years for any glimpse of NPM-139 in a published study or anywhere near to FDA approval.

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