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Moira:

Neil, welcome to the program.

Neil Klompas:

Thanks, Moira. Really happy to be here.

Moira:

Now today is a story about even with all the diagnostic tests we run when something goes wrong, how we can miss something hiding in plain sight. So let's start with a person who spent the last three months in back pain, early back pain, hasn't been around a long time, but it's three months. They have to do something about it. It's not going away by itself. So it's time to take action.

Moira:

So take us there, Neil. How common is it for people to find themselves in this situation? It's gotta be millions.

Neil Klompas:

You're right, Maura. The data shows that about twenty eight percent of The U. S. Adult population suffers with back pain. That's a large number.

Neil Klompas:

That's about seventy two million Americans are living with some form of back pain. A lot of people, myself included sometimes, just kind of accept it as part of sitting at a desk or not getting enough exercise, and it's unfortunate.

Moira:

Now, for many people, ultimately, they go to their MD. What happens then?

Neil Klompas:

Oh, great question. So you'll go to your physician, and you may have already tried things like massage therapy or chiropractic or physical therapy. And this is when the doctor has to start teasing apart what could be causing your back pain. So they'll first wonder, well, is there something mechanical? Have you lifted wrong, twisted wrong?

Neil Klompas:

Are we in a car accident, sports injury? They'll rule out all the early stuff and they'll try to rehabilitate the back because it could be muscular. But after a while, if the back pain continues to get worse, they'll start to look for other reasons that you could have this persistent chronic back pain that just won't go away. At this point, they'll start to consider other reasons for the back pain, and one of the things they may consider is whether or not this is an inflammatory back pain caused by the immune system and not mechanical in nature. This is similar to when you've got joint pain, and it's a form of arthritis that we consider rheumatoid arthritis, which is inflammatory joint pain.

Neil Klompas:

Part of this is trying to figure out if there are any lab tests that can be run. They may send you for an MRI. They may refer you to a rheumatologist at this point. But this tends to happen when everything else has been ruled out. Unfortunately, a form of inflammatory back pain, which is the leading cause of back pain, is an autoimmune disease called axial spondyloarthritis.

Neil Klompas:

Sorry. Okay. So I'll back up. Alright.

Moira:

Yeah. Yeah. You're you're getting ahead you're getting ahead of me. That was we did yeah. Yeah.

Moira:

It's like, so you go to a rheumatologist, and a rheumatologist is going to run is going to be looking at a number of things. And some That's right. People will come out with no diagnosis at all. Something like that. Okay.

Moira:

So so you pick up there, like, then you get referred to a rheumatologist or

Neil Klompas:

Great. So then you get referred to a rheumatologist, but in some cases, axial spar inflammatory back pain won't get picked up at this point.

Moira:

You've got to restate that, because you said axial goes away.

Neil Klompas:

Okay, so we're staying away from axial right now, we're just focusing Right, on

Moira:

right.

Neil Klompas:

So at some point, you'll get referred to a rheumatologist. But unfortunately, this disease, the cause of the back pain may still not get picked up.

Moira:

Now for some people, this diagnostic journey goes on seven, eight, nine, ten years, and you're still in pain, and there is no cause that can be found at least.

Neil Klompas:

That's right. The average global time to diagnosis for inflammatory back pain is between seven to ten years. In North America, the the average is about nine years, unfortunately.

Moira:

Now let's go back to that part of your story where the doctor has decided, you know, this might be inflammatory in nature. We can find nothing mechanical. And we've given you a general rheumatoid arthritis test, and, that comes up negative. Don't have that. But that doesn't mean you don't have inflammatory arthritis in your spine.

Neil Klompas:

That's right. There's a form of inflammatory arthritis in the spine called axial spondyloarthritis. This is one of the main causes of back pain. It's a form of inflammatory back pain, and until now, there hasn't been a great diagnostic tool to give doctors and patients the information they need to actually determine the cause of this back pain, and this is where we come in.

Moira:

But that doesn't mean so what I'm trying to say is that there's this form, and this is, of arthritis, and the World Health Organization say this many people in The UK, this many. Sure. And and it's diagnosed by rheumatologists. It could be diagnosed by the rheumatologist by actually ruling out every other test and making a guess that it could be this. You know?

Neil Klompas:

And we should be clear. They do use two lab tests as well as MRIs to help make that diagnosis, but they're imperfect.

Moira:

Yeah. So they have this sort of an imaginative leap to say, well, maybe it's this condition. So they can do that. They can find it, but they do it by a process of elimination of MRI and other tests. Is that right?

Neil Klompas:

The doctors will do the process of elimination. By the time you get to a rheumatologist, if if you're seeing a rheumatologist, their their job is to check for axial spondyloarthritis.

Moira:

Okay.

Neil Klompas:

So yeah. The doc the g the GPs are gonna rule everything else out.

Moira:

Okay. Good. Alright. Now let's go back to that part of the story where mechanical has been ruled out, and it's probably inflammatory. You've received a general rheumatoid arthritis test.

Moira:

Clearly, you don't have rheumatoid arthritis, but that doesn't mean you don't have inflammatory arthritis in your spine.

Neil Klompas:

That's right. The data on prevalence shows that about one point four percent of The US population likely has a form of inflammatory back pain known as axial spondyloarthritis. That translates into about four point five million Americans living with this disease. The data also shows that about ten-fifteen percent of all undiagnosed chronic back pain is likely attributable to inflammatory causes. That's a huge slice of this general back pain population, that seventy three million Americans living with back pain that we talked about earlier.

Moira:

You know, I'd like you to start with that, if you could you know, because it's like, doesn't mean you don't have inflammatory arthritis. Okay. But, it's like because of all of these 70 people have a little tough with the little percentages, but they have no problem with millions of people. You know? So just to say that it's like, well, of the people with inflammatory back pain, you know, the seventy two million, some four and a half million.

Moira:

I don't know whatever numbers you were just saying. Yep. And then break it down into now if we're just talking about this something called axial spondylo that the World Health Organization predicts this and predicts this. So we're talking about it's a real thing and it's hard to diagnose. Let's just give give it another shot here.

Moira:

We'll get something Yeah. Sure. Going on. Okay. But but that doesn't mean you don't have inflammatory arthritis in your spine.

Neil Klompas:

That's right, Moira. Of the seventy two million Americans living with back pain, the data coming out of world health organizations and leading universities tells us that about five million Americans are actually living with inflammatory back pain as the true cause of their chronic back pain. This is due to inflammatory sources, and not lifting or twisting wrong.

Moira:

And it's not picked up by the rheumatoid arthritis test?

Neil Klompas:

No. While it's similar, axial spondyloarthritis, the form of inflammatory back pain we're talking about, is just different enough that the main blood tests for rheumatoid arthritis don't pick it up.

Moira:

So what has Agarex done?

Neil Klompas:

Agarex specializes in lab tests for inflammatory conditions, and we recognize that there's a big need in the inflammatory back pain space.

Moira:

So I'm just saying, let's just cut to it. You found a unique Alright. You cut you found a unique signature in the blood for axial, and you developed you created a blood test.

Neil Klompas:

Perfect. We'll jump right to it.

Moira:

And then, yeah, you're working with Canon and everything. Just jump right

Neil Klompas:

to it. Yeah.

Moira:

And what has now what has Algorix done?

Neil Klompas:

Algorix found a unique signature in the blood, a biomarker that helps diagnose axial spondyloarthritis, a first of its kind test that we're very excited about. We're working with the U. S. FDA, who recently gave us breakthrough designation because of the high unmet medical need, and earlier this year, both Health Canada and The UK's MHRA approved this test.

Moira:

So we're talking about it now it's coming forward, and you could take this test earlier then, right?

Neil Klompas:

We're excited about it. We hope to be able to launch this test across The United States in the spring of next year as we continue down the regulatory pathway and continue working with major labs and the FDA to make this available to everyone.

Moira:

Okay. So let's answer the the question I was saying, do you could take this right away when you you know, at sort of at the three month mark, and you say, What is available? And we're we're getting closer and closer to that. You know? Okay.

Moira:

So let me try to go in. So at the three month mark, when you first come in and say, doc, we gotta do something about my back, you could take this test right away.

Neil Klompas:

That's our hope. When it's available, it can be used early to help diagnose or rule out inflammatory back pain. And for people that do have inflammatory back pain, our hope is we get rid of that seven to ten year delay where the damage to the spine, it just keeps developing.

Moira:

Okay. So all this hope, wishing, and hoping, we're all hoping for that. Now it's what you've done. And the thing is just like, that's exactly right. You know?

Moira:

But we have to understand, we're in the process of approval right now. We've gotten you know? See, you you say yes, but you back them off. Okay. Okay.

Moira:

So so see, when I don't write them down, I have to really think about it.

Neil Klompas:

I can just jump right into that and

Moira:

see if

Neil Klompas:

can take up

Moira:

what you say. Yeah.

Neil Klompas:

Yes. But we're in the process of approval now.

Moira:

Okay. So that just doesn't work. Yeah. Yeah. It's not selling.

Moira:

Nope. You gotta be yeah. More like, exactly. That's exactly the idea. Now we're in the process of getting we're we're in the process.

Moira:

We're we're talking right now with the FDA. You know, you just give you know, like, okay. So that yes. Yeah. That's a good idea.

Moira:

Say, yeah, that's the idea. Now we're talking to, you know, the people in, you know, in Health Canada and whatever you wanna say. Yeah.

Neil Klompas:

Exactly. That's the idea, Moira, that when people come to see their doctor with back pain, this can be done really early. We're in the process of talking to FDA. The initial breakthrough designation means we're on the right track, so we're hoping that it'll be available soon in The US.

Moira:

Now, you're also working in Canada and The UK, right?

Neil Klompas:

We are. We're trying to make this available to patients around the world because chronic back pain happens everywhere.

Moira:

Okay. So is it approved in Canada and The UK? Not really?

Neil Klompas:

It's approved in Canada and The UK, but it's not available yet. We're just doing our scale up manufacturing right now.

Moira:

Oh, okay. Yeah. We just we just got approval, and that kind thing. Okay. Okay.

Neil Klompas:

So it's Exactly, Moira. That's the idea. Our hope is that when patients come in with chronic back pain early in the process, after three months, as you said, they can get this test and get guided down the right pathway for treatment and diagnosis. We're still in the process of working with FDA. The FDA recently gave us breakthrough designation because of the high unmet medical need.

Neil Klompas:

Earlier this year, we got early approval from both Health Canada and the MHRA in The United Kingdom. So our hope is this will be available everywhere soon.

Moira:

Now sometimes, I hate new health conditions or new diagnostics because it often means you need new drugs. Once you get this diagnosis, where to from there?

Neil Klompas:

That's where we're in luck, because many of the drugs that are used to treat rheumatoid arthritis are the same drugs that are used to treat axial spondyloarthritis. The TNF alpha inhibitors. Yeah. This is too much detail, isn't it?

Moira:

Well, I don't know. Maybe it might be a nice testing of of this. Yep. You know, if you know those diseases, it's the

Neil Klompas:

TNF alpha inhibitor. Drug names in just so people know that there's some options out there.

Moira:

Okay. Okay. So just go ahead. It often means you need new drugs.

Neil Klompas:

This is where we're in luck, Myra. Many of the same drugs that are used to treat rheumatoid arthritis are the same drugs that are used to treat axial spondyloarthritis. Drugs like Humira, Taltz, Bimzalks. There are many viable treatment options for axial spondyloarthritis, which means this disease can be treated if we can diagnose it early.

Moira:

Okay. Now say for everyone, it's a little tough on the radio or in podcast form, what's the name of this condition?

Neil Klompas:

Axial spondyloarthritis.

Moira:

So it's basically inflammatory arthritis in your spine.

Neil Klompas:

Exactly. That's it's an autoimmune condition that impacts your spine with inflammatory back pain.

Moira:

So it's hiding in plain sight. So watch this space. You know, hopefully, this diagnostic will come through soon and be used early.

Neil Klompas:

That's really what we're hoping for, Moira. The diagnostic delay of seven to ten years where people are living in pain, not knowing what's causing it. Hopefully, we can make a real difference and get people diagnosed and treated early and get them back to normal healthy lives.

Moira:

Now, Neil, I'm, we are recording this on Veterans Day here in The US. You're Canadian. You're in Canada. It's Remembrance Day there. I just found out that you were an army medic in the in the Canadian forces.

Moira:

Tell us about that and how that relates to what you're working on now.

Neil Klompas:

Yeah, Maura. You you're right. Before I got into biomedical research, I worked as a medic with the armed forces, and I served overseas with the Canadian Army. I worked closely with some of my colleagues in the US Army at the end of Gulf War Then when I was done with that, I worked as a paramedic, putting myself through college. A focus on alleviating suffering, just figuring out how you can really help people has always been my North Star when it came to developing new diagnostics or developing new therapeutics.

Neil Klompas:

By eliminating one of the major causes or diagnosing one of the major causes of back pain and getting patients treated early, it kind of aligns with my values and what I've been doing most of my career. It makes it easier to get up and go to work each day.

Moira:

Yeah. I bet you get up and get working really fast. Get in there and get it done. Neil, thank you so much. I hope you come back and, see us again and keep us updated.

Neil Klompas:

Definitely, Mara. I will. Thanks for having me today.

Moira:

Boom. Out of the park. There we go. You can go back in.