Speaker 1: 1:25

All right, welcome to the show everybody. This is the Next Level Human Podcast. I'm your host, dr Jay Tita, and today I have with me Alex Martinez. He is the CEO and founder of Intrinsic Medicine and is doing some really neat things. I'm going to say a little bit about why I became interested in him and really selfishly wanted him here to educate me on some of the things that he is doing. And so, as it normally happens, being a podcast host, you oftentimes get reached out by promoters and people who essentially have an expert that they're saying, hey, you might want to have this particular person on your show. And so Alex came across my desk this way and I went and looked at what he is doing.

Speaker 1: 2:09

And many of you who follow naturopathic medicine, functional medicine, know that one of the mainstays of our work is really around gut immune function, and so we have seen for a very long time. Just as a reminder, I graduated from medical school back in 2004, started in 1997. And back then no one was talking about the gut and the immune system, but we got that as one of our first courses. We learned before our gut restoration programs how integral the gut immune connection was, so it's been really neat to see this, especially over the last 10 years. Everybody talking about this, influencers even talking about this, and I think Alex and his company are doing something really, really cool here. So, alex, the first question I sort of want to get into as we begin this discussion is obviously intrinsic medicine is doing a lot around this recognition of gut and immune function, and you all are coming at it from a different perspective, and so what I want maybe to ask is how you came to this in general, and then what is it that intrinsic medicine is doing that's so different?

Speaker 2: 3:23

Awesome. Hey, thanks, jade. Thanks for having me Excited to speak to you about this. So what's? It's a pretty fascinating story to some, but it's essentially is you know, I came to this after a pretty different career path.

Speaker 2: 3:42

You know, studied public health, was actually a corporate attorney, practiced in Silicon Valley doing med device work, and really the running theme in my life was I wanted to figure out a way to help people and without becoming a doctor, tried that early in undergrad and it didn't work well. So I took a health policy route, realized a legal education would be important to that. Realized that the mere practice of healthcare law was actually perpetuating dysfunction in the system. Recognized innovation as an opportunity. So I actually helped spin out a couple of companies when I was in law school and then found myself at a premier group in Silicon Valley doing the most boring work for the most interesting companies, and so never one to sit. Still, I shortly started my first company, which was an MIT spinout, which was digital health. It was a patient education at the point of discharge company. We re-engineered the patient discharge experience. This was before digital health was even a thing and paradoxically, I discovered at that time the CEOs of hospitals loved what we were doing. We kept patients, we prevented readmissions. Cfos did not. They said that's actually where we make our money from, right, and so what a striking fact pattern to be living so moved on from that after drafting part of the Affordable Care Act that actually created the financial penalties for readmissions. So that was a parting gift and was lucky enough to get a very unique role that I was grossly unqualified for, so I had to get it by actually doing a project for the company.

Speaker 2: 5:16

But I got to run corporate development, competitive intelligence and market research for a biotech company called Ionis that was developing mRNA targeting therapeutics mRNA targeting therapeutics and so that was kind of my infiltration into biotech and my opportunity to learn. The business at a key inflection point Helped to take Ionis from a small cap company to over $10 billion company with four approved drugs, which really creating a third new drug discovery platform. And it was all about antisense targeting mRNAs, primarily for monogenic diseases. And this is when I learned something very interesting that sometimes companies look at their toolkit and they say, oh, let's apply this to everything, including maybe some GWAS markers that are not monogenic, that the disorder is more multifactorial and then risk-benefit really changes. So at that time they were doing some cardiometabolic diseases and I was like I don't love this and it turned out to be the neurology programs and I got to work very closely on the program. That was the first drug ever approved for spinal muscular atrophy and that drug did have Lazarus effects. You could give it to babies early enough and they would develop normally versus generally dying by the time they were two years old. So that was a privilege to work on that. But sort of right there in my mind the entire time as I worked at another program that I would say wasn't that great and actually had some very severe side effects is who's developing drugs for the rest of us?

Speaker 2: 6:58

Because all of pharma was saying let's focus on rare diseases because there's a wide leniency in terms of safety. And then everyone flips around and sells these drugs for half a million dollars a year. And I'm coming from a health policy, a public health perspective I'm saying this doesn't sit right Not to say that rare disease patients don't deserve attention and efforts. But we have a chronic disease epidemic and what we've learned from the Human Genome Project is that genes are not deterministic. So myself and my co-founder, who also worked at that company. He was like me. Somebody couldn't stick to their job description. He was a patent attorney, medicinal chemist turned patent attorney, turned running regulatory affairs for that same company.

Speaker 2: 7:43

We recognized that the ultimate arbitrage opportunity in pharma would be safety. Opportunity in pharma would be safety. What if we could find truly safe compounds? And then we said, well, how do we stop siloing disease? And this is probably something that you talk about in your practice. Let's not silo diseases. Let's look at the common causal drivers. And we said, well, what's what's common to all these chronic diseases? And we're, it's immune, dysregulation and dysbiosis. And then you know, so you have that. And then you probably have a layer of genetic susceptibility and a loss of regulatory function from other environmental factors and lifestyle factors. Well, we just outlined a pretty compelling profile for something we'd want to do.

Speaker 2: 8:31

It needs to work through those mechanisms and be absolutely safe. Where are we going to find it? How are we going to find it? And that's why I said, well, the only lens we should look at is evolutionary biology. Let's look for compounds that appear at unique junctures in human development, starting in early life, compounds that appear at unique junctures in human development starting in early life. Let's see if there are any compounds there that appear sort of nowhere else.

Speaker 2: 8:56

And we came across a library of compounds called human milk oligosaccharides in an infant nutrition lab and the first thing I recognized is that, well, these are not nutritional because they're amylase resistant. The body can't break them down for calories because their amylase is resistant, the body can't break them down for calories. So, after fat and lactose, why is nature having human mothers produce these at an unprecedented diversity of structures and concentration? And furthermore, we also, at that same time we're looking at they're not just in milk, they actually enter maternal circulation during the first trimester. They actually enter maternal circulation during the first trimester and they're in the fetal cord blood and they're in the amniotic fluid. So literally from conception to several years out, literally encompassing the entire mother-infant dyad and then promoting the baby's, I'd say say, foundational immune and microbiome programming after birth. So took a look at this and said, well, I don't have to develop a drug. Nature already did. I need to reintroduce it.

Speaker 1: 10:01

I love this man. I'm just like. It's almost like you took the engineering approach in your career, right, and, like me, you and I are similar in this. I've traveled an interesting path. I mean, it was biochemistry, psychology, functional medicine, transpersonal psychology, philosophy, and what's interesting about when you come at it from this perspective is you get people who are very integrative thinkers right. So I always like to think about what is real intelligence? Well, it's not just gathering information, it's being able to put different pieces of information together in interesting and novel ways, and it's interesting how your story got here. And then you began to look at these compounds, so these human, identical milk oligosaccharides right, this is what you all do, and so this came from the human milk oligosaccharides and I'm interested.

Speaker 1: 10:51

You said a couple of things there that I know. I have a lot of practitioners listening, so let's just deal with this just for a minute. So these things are not being digested, right, was what you hinted at here. So they're obviously being taken in to the infant. They're also around, as you pointed out, prior to birth, but they're being taken into the infant. They're also around, as you pointed out, prior to birth, but they're being taken into the infant.

Speaker 1: 11:12

I assume the name human milk Oligosaccharides that they are very high in quantity in the mother's milk, and so the child is taking these compounds in. They are not being digested in any way, and I'm assuming, since you mentioned, they're found in the blood stream of mothers as well. They are going intact into the system and having some type of major impact there. And, given what you do, it seems that they are having an impact on the immune system, and we know that the gut and the microbiome of the gut is the seat of the immune system. So this story is starting to get pretty interesting here, given that we know that the immune system is highly regulated and differentiated at the level of the gut, and now we have these compounds that seem to be acting right at this particular, you know sort of area, and so you have honed in on this area. Now tell us a little bit about what exactly these things are doing. What do we know about?

Speaker 2: 12:20

Yeah, yeah, great question. And so what's nice, especially since I think a large portion of your audience probably is familiar with kind of plant-based oligosaccharides, they'll appreciate some of the nuanced differences in the mechanism here. So, as you alluded to, there's definitely a systemic effect. One of the fascinating things that this is actually the sort of inception Sherlock Holmes moment of the company was there's been a longstanding observation that mothers with autoimmune conditions rheumatoid arthritis, others often during pregnancy they go into remission even though they're off their drugs, right. And so if you go back in history to the 90s, that actually was an observation that resulted in the search for something called Substance X, and actually the urine of pregnant women was fractionated and different compounds were isolated and tested and one of them, substance E, actually seemed to be effective on rheumatoid arthritis at the time when really there were no treatments, and that turned out to be cortisol. So that was a discovery of cortisol. It was synthesized as cortisone. They won a I think it was a 1950 Nobel Prize for that. But if you actually read their laureate speech, they said well, we actually didn't find substance X, we don't believe cortisone was that, but we found something that worked and it's still a mainstay, you know, of course it has some chronic side effects and but you know the the the the aha moment came was the same exact year 2018, that I'm looking at these human milk oligosaccharides and understanding their mechanisms a little bit better. That was the same year it was discovered that they enter maternal circulation, starting the first trimester, which corresponds to when the historical observations of remission have been seen. At the same time, there was also a cohort that was an epidemiology study in Canada looking at 521 mothers, including some with existing RA, and they looked at ones that went into remission versus ones that did not. And the ones that did go into remission had a single had a unique elevation in a specific human milk oligosaccharide in their milk which corresponds to the levels in their serum and the p-value is like 0.001.

Speaker 2: 14:49

And then they and that formed a hypothesis and they said well, what if we put this in a mouse model of rheumatoid arthritis? What does it do? And lo and behold, it works, disease modifying. So that's one of the things that's unique is you have a prebiotic here that's entering the colon intact. It's the preferential substrate for bifidobacterium, right, right, but these work by very symbiotically with our symbiotes. They upregulate adhesion genes in the bifobacterium so it can create a biofilm.

Speaker 2: 15:22

They actually can break up existing biofilms as well, and then simultaneously these are, they're sugars, and sugars are a language that mediate a lot of intracellular responses, including pathogen-host interactions. Sugars on cells are doorways that are hacked by pathogens to enter the body. So some of these HMOs, they actually serve as soluble receptor decoys. So as they're terraforming that microbiome you can have invasive E coli microbiome. You can have invasive E coli. You can have H pylori is binding to these instead of the baby's immature gut cells and being passed out.

Speaker 2: 16:03

So that's how it disadvantages and really enables a healthy foundational microbiome to be formed and then once that happens as substrates for the commensal microbes, basically turns them into little drug factories and they are just spewing a whole host of small molecules and metabolites, including, like butyrate, of course, other short-chain fatty acids and then even neuro neuroprotective, neuro neurodevelopment compounds as well. And then to your point about the sort of direct immune modulating activities. Here that's when things get interesting. So about like one to 4% of these do enter systemic circulation. This is essentially the bootcamp for the immune system and they work on, they balance the immune responses with Th1, th2. And we've actually seen that independent of any of the microbiome effects, so we can do it in completely a clean environment. We can change macrophage polarization from like a M1 to a regenerative M2. Phenotype also enhance Tregs as well, and it makes absolute sense. They're helping terraform the microbiome. The baby's immune system is being trained to recognize self, non-self as well as friends, not friends, and so that's kind of how they work.

Speaker 1: 17:35

Yeah, and now I think the listener can understand why, when I started looking into this, I got so excited because this is one of these things that works with the body's immune system and sort of the things that we have in place, our microbiome, to do what a healthy system would be doing anyway. Right, and so it's one of these things that I was just like. This is a really interesting set of mechanisms, not just one simple mechanism. Of course, one of the things that my medical background taught me right from the get-go is, you know, sort of this integrated, holistic approach in both the approach of the practitioner but in the way the body works.

Speaker 1: 18:13

So many of these drugs that we take, they are big guns focused on one particular area, and this can cause downstream effects, because our physiology is like that spider's web you touch one part of the web, everything else moves, and so having compounds like this that influence multiple aspects of immune function, from the bacteria to the actual cell membranes, to actual immune cells and modulating those cells, is really incredibly fascinating. So I would imagine and this is my next question that for me, with knowing nothing else, I would be thinking about, obviously, autoimmune conditions, I would be thinking about allergic conditions, atopic conditions. Do we see that these things are having an impact on these conditions, and to what extent are they? Is the research already there? Is this emerging research? But we can begin to guess that this could have far-reaching effects, even in things like cancer and other things like that. So I'm curious what have you actually seen these compounds be able to do in terms of disease?

Speaker 2: 19:29

Yeah, it's a great question and actually a really exciting one, because there is substantial preclinical data and sort of translational data suggesting that these can be disease-modifying in the conditions that you mentioned. As I told you, the sort of Genesis story is pretty fascinating because you have kind of a human epidemiology with a direct nexus to it. That was, then, what I like about some of these studies is there's there's always a human epidemiology component, whether it's coming from mothers or infants, right, because we can also look at infants that are formula fed, right, and and there's also a human knockout model, for that's actually based on on on secretor status, blood group, where some moms have a markably different HMO profile in their milk, including one of the foundational ones, and what you can see is you can see completely different trajectories in terms of health and it corresponds to a different microbiome. And then you're able to do reverse translational. You're able to form a hypothesis and do a reverse translational experiment in mice, which is important for drug development, of course, and I think one of the other things you know, I like how you appreciate the kind of meandering path because, you're right, it enables a different form of pattern recognition and sort of bias, uh, where you're like I just it was. I just want to find the truth behind something that's intriguing that no one's found the truth for and it's not mine, I didn't invent it.

Speaker 2: 21:06

Uh, there's a a different responsibility associated with it and, you know, one of the things that is pretty annoying, quite frankly, to me is the lack of translation of of studies that are published in nature. They're published in science, are published in cell, and they don't make it. The biology just seems to peter out, usually after a company has raised a ton of money and and in the popular science media has already put out some articles saying these geniuses at this, these, you know, elite institutions, may have found the cure for blank right, creating hope in patients, and it just never, never gets there. Yeah, and that's why, when you look at, uh, you know the, the perverse statistics in the pharmaceutical field, they're saying now the cost to develop a drug is $3 billion. That tripled in the past decade. So this rebuts the solo residual right. Wait, technology is supposed to make things cheaper and faster. Instead, it's longer and more expensive and when something does get across the finish line, it's expensive to the system line. It's expensive to the system and it's really expensive to the patient and oftentimes it has a mediocre profile at best.

Speaker 2: 22:23

So, that rant aside, it was saying how do I remove that kind of translational risk? And there's a lot of reasons you can talk about it. Fraud is actually one of them, but a lot of it's the imperfect nature of animal models, mouse models, especially when they're genetically manipulated. You're creating something that's essentially so artificial. It's designed to give you a conclusion that matches your hypothesis, so there's a subconscious bias that's been introduced even in preclinical proof of concept. So that's a long way of saying guess what?

Speaker 2: 23:01

These are not just human milk oligosaccharides, they're mammalian milk oligosaccharides, and so we've prioritized our initial candidates that we really want to kind of prove this thesis on, based on ones that are common. So these are not artificial constructs. It's is the biology preserved so we're able to look at, you know, every single different rheumatoid arthritis model. These work disease modifying. They've been tested against things like methotrexate high dose methotrexate high-dose methotrexate a human mainstay disease-modifying effects, reducing the systemic cytokines you want to see, but even promoting cartilage repair and even like PANIS and bone erosion reductions as well as edema swelling. Same thing in atopic dermatitis models as well, and you see a reduction in the validated cytokines IL-4, il-13, where we do have DMARDs and, importantly, these are same things with human cells as well, with the corresponding human cells, the monocytes and the T cells, and seeing basically the translation at the cellular level of the effects that led to the in vivo did to the in vivo?

Speaker 1: 27:14

Yeah, and just real quick, alex, let me, for the listener, for those of you who are getting a little bit lost with Alex talking about the science here, basically what he's essentially saying is, as compounds go through sort of the rigor of seeing if they're going to be effective for a disease or diseases, they go through a process, usually in vitro, meaning in test tubes, petri dishes, that kind of thing, and then in animal studies prior to going into, maybe human cells in petri dishes and things and then finally into clinical studies. And so what Alex is walking us through right now is how this is going in sort of the in vitro animal world, showing that there are disease modifying effects. And the next step is going to be and that's what's going to be the next question I was going to ask Alex is do we yet have any in vivo or clinical trials unpublished in humans yet? And I think, from what I heard you before, that's not yet the case, but maybe there is some of that going on. But the interesting thing is that, you know, obviously these things have been in human milk since the beginning of humanity. They're in mammals.

Speaker 1: 28:21

This is what he's talking about, and so we have an interesting way of looking at this, because this translational material, the in vitro studies, the animal studies, along with this idea of evolutionary biology, knowing that these things are there makes this incredibly intriguing. And of course, one day we will get to, hopefully, clinical trials, if they're not here yet. But I just wanted to give everyone who's not skilled in the science of this a catch up to understand where Alex is with this. And then, alex, do we have and how far off are we all from sort of human trials with this? Is that stuff going on behind the scenes right now or not, or can you even tell us?

Speaker 2: 29:01

Yeah Well, thanks, jade, and first of all, you know, yeah, thank you and apologies to the audience. Sometimes I jump into my nerd hole.

Speaker 1: 29:08

Yeah, I like, don't worry, I like it man.

Speaker 2: 29:18

I like it and so. So thank you for offering that context. So one of the neat things here and again my premise was safety is an arbitrage opportunity, right, and so it was actually the infant nutrition companies that they've spent a lot of time, they've been working on this for decades and part of that included. You know understanding, you know the safety profile of this. So manufacturers of these compounds? Of course we're not. We don't have a. There's no human dairy out there. So these are being produced with synthetic biology and so that that pioneering work has occurred and the manufacturers have demonstrated the bioequivalency, so it's equivalent to the natural thing and that they that it's super safe.

Speaker 1: 29:53

Yeah, and let me just say something about that, because you and I know that people are going to ask this question as well, and just for those of you who are, again, not practitioners and concerned with this kind of stuff, whenever you hear things like you know, built in a lab, or something like this, what a lot of people don't know is if you take vitamin C, for instance, and you take it from an orange right, like that vitamin C, and then you make vitamin C in the lab, those two vitamin Cs are completely alike, okay, so like they're basically the exact same thing, and a lot of people sort of get upset about this.

Speaker 1: 30:26

All that's left is vitamin C. And so when we talk about and I guess this is my next question so these are bio-equivalent, they are essentially the same thing. Is that what you're saying, alex? That these are human identical oligosaccharides, human milk identical oligosaccharides, so that while they are made in a lab, they are the exact same compound in terms of the way they look, function in the body, and that's what we're talking about here. But we cannot say that they're direct because, as Alex said, we don't have a dairy factory for human milk and so these are being engineered in the lab. In the same way, insulin might be sort of made in the lab.

Speaker 2: 31:07

Yeah, absolutely correct. Yeah, and they're truly bio-identical. They're absolutely identical. And they're truly bio-identical, they're absolutely identical. And part of this that's ethical right, because you can isolate this from donor milk. But then what you've done is you've diverted this from babies that need donor milk. So it's something that's certainly important for us.

Speaker 2: 31:29

There are some companies that are taking it from donor milk and I disagree with that. And also that's a pool. There are actually 200 distinct structures of these and even ones that are same exact building blocks, but the bond angle is different on the structure, completely different bioactivity. So there's a ton of work to really understand what the merits of each structure are and what the applications are. And that actually leads to your question about where we are in terms of clinical studies. So safety has been established in human beings already, not long-term, but long enough to get into meaningful clinical studies. We've met with FDA on that and on the basis of that we've been even approved in Australia to get into like meaningful clinical studies. And we've met with fda on that and on the basis of that we've been even approved in australia to get into two different phase two clinical studies. And just so everyone knows, phase one is typically the safety studies, um, and that's usually in a healthy, normal volunteer population. And then a phase two is really kind of where the rubber meets the road, where for the first time you're putting the compound into a patient situation and seeing if not only is the safety preserved in that patient population but does it do something that's clinically relevant to them.

Speaker 2: 32:49

The lead compound that we are developing is the most abundant of these human milk oligosaccharides, so it's like 30%. If they're 200 different structures, this one is like 30% of the concentration. So it's really important for something and, as I mentioned, there is a human knockout model. What I mean by that is that some people have different genetics so they don't produce this most abundant HMO in their milk and that also corresponds to they don't produce a similar oligosaccharide that lines their mucosal tract, including like the GI, and it's identical. The oligosaccharide is identical between the milk and the one that lines their intestines and mucosal tracts. So those people that are missing this they have a different microbiome West Bifidobacterium and they get inflammatory bowel disease. So this compound is actually being tested at Cincinnati Children's Hospital right now in pediatric and young adult inflammatory bowel disease.

Speaker 1: 33:49

And is this 2-FL? Is this the compound? Yes, yep, okay, yeah, so that's 2-FL. Is this the compound?

Speaker 2: 33:53

Yes, yep, okay, yeah, so that's 2-FL so this is fucosyl lactose.

Speaker 1: 33:59

Yes, yeah, how do you say that? Yeah, how do you say that?

Speaker 2: 34:02

Yeah, yeah, two prime fucosyl lactose yeah, yeah, and yeah, so that's being assessed in that population. And, interestingly enough, at that same hospital who's a partner of Intrinsic Medicine they had a phase two. That was a controlled study. It's actually the first controlled study. No one really knows about this study so I really want to give them credit for it.

Speaker 2: 34:25

It was in children and young adults that received bone marrow transplants, that got allergenic bone marrow transplants, and these are really sick patients yeah, no kidding. And the prognosis for that has been known to be because they're at risk of, basically, a graft rejection. You got a transplant with someone else's genes in it. The immune system can reject that and kill you basically. So these transplant patients are put on tons of immunosuppressives, but there are still ones that get what's called like it's like a steroid resistant acute graft versus host disease, where their body basically attacks the, the transplant and, unfortunately, like the mortality is extremely high when you have that rejection and it's happening systemically, meaning in your GI tract or in your liver, and so you know the scientists and clinicians taking care of these kids are saying, like, well, what determines whether someone gets that or not? Patients who have dysbiosis. It makes sense. They have a dysregulated immune system as a result of that dysbiosis, so it's more primed to attack and cause this really severe and fatal consequence.

Speaker 2: 38:48

So the hypothesis was hey, we know 2-FL can rescue dysbiosis, maybe we can try it in these children and see if we can change that. And so they did that in the study. It was a controlled study 25 patients received 2-FL, 20 didn't, and not only were markers of the dysbiosis improved, but none of the patients that received FL had systemic acute graft versus host, compared to four in the control group that did not receive it and the overall occurrence was very striking. Only one patient had a skin graft versus host in the 2F, which is a mild one, which actually has a good prognosis, and in the controlled ones that didn't, it was five patients had nine total occurrences. So you had patients that not only had systemic ones but they also had the skin ones, so it was a full-.

Speaker 1: 39:49

Yeah, so a small study, but a huge impact. Huge impact Two prime fucosal lactose was having marked effect on these children.

Speaker 2: 40:00

Yeah, yeah, and it was, and you know, and I think it would have seen a bit of a wider recognition their p-value if they were underpowered by a couple of patients yeah, yeah, that's, yeah, that's what I was thinking, yeah it was 0.07, which is like it's pretty darn close.

Speaker 2: 40:18

Yeah, so they're off by a couple of patients, but we're still going to be talking to regulators about, like, what we can do with that. No, I think that was an important study. And then, you know, going on to the programs that we're running, we're actually getting ready to initiate a Parkinson's disease study in Australia at the beginning of next year with Phell. What's interesting here is this is really, I think Parkinson's is almost kind of like the prototypic gut-brain axis disorder and it's really been in the past year that that's come out in a striking way. I guess last summer there was a 25,000 patient that was published in Gut BMJ and it showed basically, if you had constipation, your odds of getting Parkinson's are like 400% higher than anyone else. And then, I think just a couple months ago in the JAMA network, another 10,000 patients published same thing constipation your risk of Parkinson's is, I think, 165.

Speaker 1: 41:20

Yeah, and you guys are all over this because I don't the listeners, any of the practitioners know. Anyone who's in functional medicine knows we've been talking for at least the last decade about, you know, this gut brain, immune sort of axis and things like Parkinson's, especially Alzheimer's is the big one, even autism, ADHD, so this is a really big area, a huge area. That actually is one of the areas, Alex, that I'm very excited about, because obviously these are huge issues and we don't have a whole lot of treatment. You know things for these.

Speaker 2: 41:51

Yeah, yeah, and it's amazing that functional practitioners have been looking at this for so long. Right, it's like it's been long recognized that the neurologists that see Parkinson's patients they said like, oh, of course. Yeah, all of our patients are constipated. And then you go into their histories and you're like this has preceded any of their motor or neurological symptoms by years. So it represents, now that we're looking at this big data set, all of a sudden, it's like constipation is a functional risk factor for these cognitive and neurodegenerative diseases and it's something where you know, I think so many people have been trained in. You know I'm against risk factor medicine that's based on biomarkers. I think you you scare people into doing something and maybe you're budging a needle on a population-wide level. But that's looking at people as statistics, when, even with things like statins, it's like what are you doing in terms of the myalgia, the muscle pain, the insulin resistant stuff? It's like you're-.

Speaker 1: 42:53

You and I are on the same page here, man. I've seen it. I just went through it with my father. Actually, you know, we put him on a statin recently and he couldn't you know. I just took him right back off you know, because it's just so.

Speaker 1: 43:03

Yeah, so we're doing some.

Speaker 1: 43:04

You know, actually, I'll give you one of my pet peeves about my field in functional medicine. One of the things that we take we might have been talking about the gut brain immune and the gut immune balance but we're doing these treatments and dietary approaches which I know I'm going to get in trouble with my fellow colleagues here, but they don't work most of the time for the things that we're really trying to help. Now, of course, we can make a strong argument they're working way better than what we were doing in the traditional realm. But this is what excites me about this style of medicine and this approach to finding solutions, and so obviously it's one of the things that excites me about you and your company and how you're approaching this, because I do think even the functional medicine world yes, we may have been talking about this stuff, but our treatments and our gut restoration programs and just giving probiotics and all the things if we are going to be honest and I think we have to be evidence-based we have to realize that this is not being that effective for most people.

Speaker 1: 44:04

Sure, it's more effective than not looking at this stuff, which the traditional medical world is not looking at this stuff at all, but it's also not that effective on the functional medicine sides Just a pet peeve of mine. I think it's important that we keep looking and rather than acting as if people in my field have figured this out just because we've been talking about it. I think we've been talking about it, but I don't think we figured it out.

Speaker 2: 44:27

Yeah, yeah, and Jade, what I'd like to add to that is you know, again, I think it's like being constantly curious, having identified the problem, and then I think that's actually a good thing that there's an imperfect solution as well, because that will sort of truncate and shorten the diffusion of maybe a new practice standard from something where people can say, yeah, we've actually done, you know, a probiotic approach. I mean, if you look at it, if you look at the trajectory on this, it started with the fecal microbiota transplants and those demonstrated that cool, you can therapeutically intervene at a systems level on the microbiome in a major way. You know, we, we look at, I look at every single FMT study as a non-competitive proof of concept, because then there's always going to be a scaling issue and then there's some real infection issues and also sometimes you achieve the effect on the disease but then you change the phenotype of the person, right, like it actually shows how much that impacts things. And so what happened in terms of like microbiome treatments is again, we're in the current state of medicine. You guys are the ones who are really breaking loose of it, are the ones who are really breaking loose of it. But if we say the allopathic approach is a reductionist, mechanical approach, not a systems approach. It's more biochem versus biology, which is an ecosystem and a system and bidirectional.

Speaker 2: 46:00

Then it's saying, hey, what discrete components of that FMT led to that effects? And then all of a sudden you have limited consortia probiotics and they're saying they're following the same thing. The association study is like GWAS and say oh, this, this bug is that one. And then they say OK, let's isolate it, let's introduce some antibiotic resistant genes, because that a completely different timescale than a human being. And so it's effectively outside of the host for geological time periods it's probably forgotten what it's like to be inside that host. And then it's reinserted and you have engraftment liabilities. And that's not to say probiotics are not without their merit, but it's probably an immunostimulatory, it's probably more of a transient, limited effect and at the end of the day, where the field's going is it matters less about who's in there and more about what they're doing.

Speaker 1: 47:02

Right and I think what you're saying here, alex, is so important for us as clinicians who are listening to this, and even those of you who are interested in this conversation, who are or who are, patients.

Speaker 1: 47:15

This, what alex just alluded to in my mind is the reason why you'll get all this marketing from different companies and different supplements, where the science is very exciting, but the translation into the actual product doesn't seem to have a huge effect. I can't tell you how many times I've seen new products come to market where people are like, oh my God, look at this amazing study and look at this thing we found, and then, based on what Alex is telling us how they come up with this, in this very reductionistic approach and not understanding how to look at this in a holistic manner, you end up with a product or a program that is not that effective, and so I do think it's interesting where we currently are in medicine. It's all important, but this sort of reductionistic approach to this without the more holistic, systemic approach is probably not going to get us there, which is why I get excited about where we're going here. So let me go ahead and wrap up with you and ask you I mean the first question everyone's going to ask. You know, this is like OK.

Speaker 1: 48:17

Where do I get this? How do I take this? What do I do with this? Alex?

Speaker 2: 48:23

Absolutely, and so, yeah, I always, always want to add something that's of value. So these are not broadly available yet there are some companies that do have them. The quality control, the purity, is certainly not up to our standards. So I'd say the announcement that I can make is, while we are a pharmaceutical company, while Intrinsic Medicine is a pharmaceutical company, I'm committed to making earlier access available for these compounds, given that they are safe, and so I will be starting kind of a parallel wellness company that offers these on a structure function basis, and initially we will be launching in collaboration with a functional medicine clinic out of Chicago and we'll be putting together a protocol of use case on this, based on clinical data, including some positive data in all different forms of irritable bowel syndrome, and we'll be producing this at a clinical grade spec, and so if people are interested in that, you can go to our current website, intrinsicmedicinecom, and just fill out the contact form and then we'll update you on that one, and that's going to be primed for a Q1 launch, but we'll have material available.

Speaker 1: 49:40

So we don't have long to wait.

Speaker 2: 49:42

Yeah, so you don't have long to wait, because and then the way I envision things working between the companies is we'll be running like true pharmaceutical gold standard phase two clinical programs on the intrinsic medicine side and on the intrinsic wellness side. Practitioners within their scope of practice can actually look at that, look at those protocols and say, cool, do I want to do this on a case-by-case basis with my patients and they'll have access to a high-quality spec material as well as practitioner-developed resources on the use of that. And that's kind of the way of saying that these compounds are for everyone and I don't want to create excitement without providing access at the same time providing access at the same time, 100%.

Speaker 1: 50:32

Well, alex, I have to say man, I just want to say this podcast right, it's called the Next Level Human Podcast. Part of the reason for that is that I believe that every single one of us are unique. There's never been another Jade, there's never been another Alex, there never will be, and your unique background and the way you came to this gives you the ability to do something that only you can do in a way that you can do it, and I really appreciate that you are doing it, alex. I really appreciate you bringing this to the world. I think it's needed. I think you're doing, I think you're just a brilliant dude and you're doing like some really amazing stuff here. So I just want to say thank you for your work, thank you for your time. Is there anything else you want to leave us with before we part ways?

Speaker 2: 51:12

Yeah, yeah. So thanks, thank you, jade. It's been my pleasure and this has been a wonderful discussion. So I think there's a couple of things. The first and foremost is that 95% of Americans are not at their dietary fiber levels, so that is a low-hanging opportunity for everyone to do an audit, for practitioners to do an audit, and even though the plant-based, the galactooligosaccharides, the fructooligosaccharides, may not have the full profile, there's merit there. And, of course, there's merit from whole foods, right, and so that's an opportunity for people to really profoundly shift their health and their microbiome.

Speaker 2: 51:58

And so I don't want to disempower anyone and say, hey, you have to wait for the next scientific miracle. There's something that truly you can do today. And then I'd say the second thing is that I had a vision when I was starting this company and said, well, we would have entirely different drugs if every CEO founder was required to be the first one to take theirs. So you know I'm not talking from a soapbox saying, hey, everyone else has to do this. I'm actually the I think the person who has taken these chronically for the longest period of time. So I'm four years in and it's constructively enabled me to cure my IBSD, which was fairly debilitating.

Speaker 2: 52:40

So and and same thing, my son had very severe atopic dermatitis. There was a milk allergy and he was, you know, zero, and we were able to get him from an EpiPen with 21 food allergies to eating peanut butter sandwiches between ages two and four. So we're living it. And now it's about creating a data set that other people can use to inform their own use case. And of course, that's also what's driving me for sort of novel commercialization to create an early access opportunity, because I do believe in practice autonomy and then personal sovereignty for people to direct their own self-care and health and wellness journey 100%. So thank you so much everyone for listening, jade you for having me and the insightful conversation.

Speaker 1: 53:32

Yeah, my pleasure, Alex. Alex Martinez from IntrinsicMedicinecom. We appreciate you very much. You all go check out the website and do me a favor, Alex, hang on the line, just so I can make sure all this uploads. But for all of you, thank you for hanging out with Alex and me and we will see you at the next show.