Matinas BioPharma’s Lipid Nano-Crystals Could Change the World

Lipid nano-crystals are something you’ve probably never heard of. But in a few years, everyone could be talking about them. Lipid nano-crystals, or LNCs, have the potential to shake up medical industry in a bigger way than doctors washing their hands before surgery.

LNCs could be bigger than the invention of intravenous injections, because they aim to convert needles into pills, making them safer, more effective, and shelf stable. The ramifications for low-income countries alone could earn LNCs a Nobel prize.

Most people would rather take a pill than a needle. It’s easier, it’s less painful, and you don’t need a nurse to administer it. Some intravenous drugs require you to sit in a chair for six hours. Even if someone invented a miracle intravenous drug that cured everything, we don’t have enough nurses, chairs, and time to give this drug to everyone.

LNCs reformulate a drug to make it safer. Here’s the thing about most drugs, they’re toxic. This means if you take too much of it, even if it’s helpful, you can have serious side effects or even die. Think about Tylenol (acetaminophen) or Advil (Ibuprofen). On the box it says how many you can safely take each day. All drugs are like this. You can take a set amount for a set amount of time before it becomes dangerous.

Too much of a good thing can give you kidney or liver damage. Our organs don’t like foreign substances interfering in their daily operations, so they fight back.

That’s why LNCs are so amazing. They are designed to deliver drugs directly to the affected cells. This means drastically less or no toxicity issues.

Progress on LNCs so far:

Let’s look at a drug called amphotericin B. It’s an antifungal medication used for serious fungal infections like cryptococcal meningitis. Amphotericin B is administered intravenously and is very effective but has serious toxicity issues. The death rate of someone treated with this drug for cryptococcal meningitis is about 28.7%.

A recent study published month in the NEJM, showed that a slightly different formulation of ampho B dropped this to about 24.8%. One of the study investigators called this “The biggest thing in years.”

Many doctors were excited about this. The different formulation was a single dose infusion, which makes ampho B easier to administer. It also increased survivability, which is the most important thing.

Now here’s where LNCs will blow your mind. There is another amphotericin B trial going on right now. It uses Matinas BioPharma’s LNC technology. Amphotericin B has been packed into lipid nano-crystals and converted from intravenous to oral.

This trial has multiple stages (cohorts) to protect patients and evaluate the safety and effectiveness of LNC ampho B compared to ampho classic.

In the first cohort, 10 patients were given IV amphotericin for five days. Then they were given LNC amphotericin for 10 days. This was to test different strengths of the drug and to see what the toxicity issues might be.

From the press release: “In the published manuscript, trial investigators reported results from the Phase 1A and 1B portions of the study. They concluded that MAT2203 was well tolerated when given in 4-6 divided daily doses without the toxicities commonly seen with IV amphotericin B.”

After that they moved on to stage 2. This cohort had 40 patients, which would give doctors a better idea whether LNC amphotericin B was working or not.

The results, were spectacular.

Remember how excited the doctors were about a drop from 28% to 24%? Well, in this cohort, there was a drop to 10%. But patients were still receiving two days of the toxic IV amphotericin. It’s possible that someone only died because they also received the toxic version of the drug. Or it’s possible their death had nothing to do with the drug. Matinas is working with the FDA to design a larger study (cohort 5) to confirm these results. This will take more than a year. But we don’t have to wait that long to find out how amazing LNCs are.

In the next stage of the trial (cohort 3) they gave patients LNC amphotericin for 5 days, and then IV amphotericin for 10 days. This is more LNC initially, but less overall. This was an important trial, but not a showstopper. The Data and Safety Monitoring Board recommended proceeding to the fourth, and most important stage, cohort 4. It’s already begun.

Cohort 4 is two weeks of LNC oral amphotericin B. None of the 40 patients will be given intravenous amphotericin. Although 16 additional patients will be given IV amphotericin to see the comparison. This is called a control arm. (You always need to test a new drug against the old drug to make sure the new one is better.)

The 4th cohort is still ongoing, but the survival spread between LNC amphotericin and IV amphotericin appears to be humongous.

This is intentional. LNC technology was designed to do this. Less toxic drugs result in less deaths.

Cohort 4 results (due in third quarter of 2022) will be the most important data to be released in the company’s history. The CEO of Matinas has already provided an interim update. They have enrolled more than 16 patients so far, and each one that received LNC amphotericin has achieved sterility after two weeks. Sterility means the absence of infection.

What this means is that LNC amphotericin is probably working. I would like to say 100% definitely absolutely and obviously working, but until the data is published you can’t say that for sure.

It’s possible there has been divine intervention. Or maybe it was space aliens that cured these patients. Or maybe cryptococcal meningitis, a disease that is almost 100% fatal if untreated, just went away on its own.

But it was probably LNC amphotericin B.

If you’re not excited about this trial because you don’t care about cryptococcal meningitis, then that’s fine. Unless you’re immunocompromised then you’ll probably never catch it.

But you should still be excited about lipid nano-crystals. Because their application isn’t just limited to amphotericin B.

LNCs are a massively improved drug delivery system.

Lipids are like a shipping container and the drug is the package you ordered online. Normally you get a cardboard box delivered to your door. These boxes are flimsy and easily damaged. They can be lost or stolen. This is the classic LNP technology. If you got a Covid-19 vaccine, then you’ve had LNPs.

LNCs are like shipping a package in a bulletproof crate. And instead of being delivered by a truck, it comes by a flying drone that enters through your window and drops the package on your table. It’s faster, safer, and more efficient.

Here is a list of the top-selling drugs. https://en.wikipedia.org/wiki/List_of_largest_selling_pharmaceutical_products

Most of these are administered with an injection. All of them have toxicity issues.

There are more than 20,000 drugs approved by the FDA. All of them have toxicity issues.

They also have stability issues. The Covid vaccines need to be stored in special freezers or they go bad. LNCs however, can be stored safely on a shelf for months. Per the CEO of Matinas, LNCs are so durable, you could “boil them in detergent” and they wouldn’t fall apart. LNCs were specifically designed to survive in the gastrointestinal tract.

This isn’t some fly-by-night company trading on the pink sheets. They have partnerships and are running studies and trials with some of the biggest names in the biotechnology sector, like Genentech and Gilead. Matinas even has funding from the NIH.

Remember remdesivir? It was the first antiviral drug approved to treat Covid-19. But remdesivir sucks. It’s intravenous and it has liver and kidney issues. Matinas is working on an LNC oral version of remdesivir. This would covert it from intravenous to oral, while theoretically eliminating the kidney and liver issues. Patients could take take it quicker, which is important for an antiviral.

Some of their collaborations are very hush hush. Genentech (which has some of the top-selling drugs of all time) was working with Matinas last year on developing two LNC formulations. Recently they extended that partnership and now they’re working on a third compound. Would they have done this if LNCs didn’t work? Probably not.

Matinas has another drug in development. It’s an LNC oral version of amikacin. This is another highly toxic drug that’s administered by an injection. An oral version with less toxicity issues would be a game changer for pulmonary and acute bacterial infections.

So, if this technology is so amazing, why haven’t you heard of it before?

One, it hasn’t been 100% proven to work yet.

And two, because there is no incentive for either Wall Street or companies like Gilead or Genentech to talk about LNCs. Matinas only has enough cash to last them until mid 2023. At some point they need to cut a deal with someone. Likely a manufacturing and distribution deal for LNC oral amphotericin B.

If you’re trying to sign a deal with someone, you don’t want anyone else excited about their products. You want to keep it hush hush until the ink is dry.

I own a lot of shares in Matinas BioPharma. Not just because I think the company is tremendously undervalued. But because of how much utility it will create for society. I love the economic concept of utility. I’ve written about it before, and I think everyone should learn about it in school.

Imagine a world where people invested in companies that don’t just aim to make great products but also want to dramatically improve our planet. That’s the type of world I want to live on.

LNCs have the potential to be a truly remarkable technology. This is your chance to get in on the ground level of a eureka moment in biotechnology. A real medical breakthrough that could improve the lives of billions.

LNCs allow the conversion of fragile, intravenous, toxic drugs to shelf-stable, oral, and safer versions. 100 years from now people might look back at toxic intravenous drugs with the same disgust that we look back on doctors that used leeches.

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