Endosane Brings New Hope For Patients With Mental Health Conditions

ABOUT THIS EPISODE

Executive Summary

Endosane is a new take on developing drugs. Endosane is a joint venture of a group of researchers (Prof. Leweke and Dr. Rohleder) and the Sanity Group. Their goal is to apply cannabinoid compounds to develop drugs for neurologic and psychiatric applications.

Our background is in neurology and psychiatry … we think this area has not received as much attention in drug development as it deserves.Max Narr, MD ENDOSANE 

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The Guest

In this interview, our guest ist Max Narr (https://www.linkedin.com/in/max-narr-6a3b2a18a), MD at Berlin-based health care startup Endosane (https://endosane.com/). He is also Chief Investment Officer of Sanity Group (https://sanitygroup.com/), which develops products out of the components of cannabis.

The Startup

Endosane (https://endosane.com/) is a joint venture of Sanity Group (https://sanitygroup.com/) and a group of researchers. Max says it is Sanity’s take on developing drugs, partly based on cannabis derivatives. Their drug development is advancing the research of Prof. Leweke and Dr. Rohleder on cannabinoids for medical use.

Sanity Group

Endosane has close ties (capital and personal wise) with Sanity Group. You can learn more about Finn Hänsel, the founder of Sanity Group, and his plans for the future in our interview with him here: https://open.spotify.com/episode/1TXps03Uxzb8hv0KvOVIpN?si=b17a5f2f3cbe40a4  

Find all links and show notes on our blog: https://medium.com/@startuprad_io/endosane-brings-new-hope-for-patients-with-mental-health-conditions-7513dcfefa7b 

Welcome to start up bread and that I own your podcast and Youtube blog covering the German startup scene with News, interviews and live emits. Hello and welcome everybody. This is Joe from start up Ratodo, your start up podcast, and you to block from Geermany, as well as the founder and host of the woods first Internet radio station dedicated to take entrepreneurship, called start up dot radio. Today I would like to welcome Max hid in. Hi. This is nice. I'm doing good. How are you? I'm doing great. Thank you. We will talk today about Endo saying. We'll get into the details soon. It's a joint venture and we know some of the people that have that are involved there. But not unless your main aim is to take medical component out of cannabis and treats psychiatric conditions with that. That is the bottom line, right. That's what we're talking about today, and let me rephrase that just a little bit towards our aim is to use the endocindem not system in the body to treat these conditions, and some of the compounds by which we do that are going to be derivatives of the cannabis plan it, but some of them are not. Some of them are not add that's an important point and we have to be very precise and right to the spot, because you are a lawyer by training. How on Earth did you get into a farmer company? I mean, without wanting to to go back to my childhood, I knew that I didn't want to be a lawyer forever, just for the simple reason that it's very subjective thing whether you're the type of person that wants to to deal with with sort of the same all very similar set of circumstances or tasks every day. I'm that's just not me and I was somebody that loved to to go into different things and to think about new problems and new structures every time. And so I took the opportunity and when presented itself, to to move, to make a switch towards management, and then wasn't as medium size chemical company for close to four years. Didn't management and mostly strategy and Ma over there and then moved into sanity group and thereby and the same leader on hi, you already mentioned Sanity Group. We have an interview with fin hinder. I do believe it's by now approximately a year old, but not unless we link it down here in the show notes for the very simple reason sanity group is basically backing and the same and this is a...

...joint venture with a research group. Am I getting this right? That's exactly right, endo saying, as part of the long term vision of Sanity Group, which is to use the endo kind of note system to help people. Basically, and we do that in all different stages, from what's possible right now and what's legal right now, which is medical flower and medical extracts, as well as Medical Api, for instance, TC. For the treatment of various indications such as pain. But we also see that on the long term the pharmaceutical world tends to gravitate towards what we call finished promaceuticals, which a lot of people know through the very well defined development stage, through preclinical and then a clinical phase one, two and three development and endo saying is the finished pharmaceutical play off sanity group. Basically we break this down a little bit Barney style for people like me who don't have any medical background wouldsoever. So basically, my understanding is one researcher, for whatever reason, finds a compound, a product chemical that has some medical qualities. Then first you experiment with animals, then with human tissue and then you go through different steps in the process of checking out if this really treats the condition you are aiming for. A very, very famous example, I do believe, add the very little blue pills that actually been intentionally created as a heart medication but do have surprising side effects. That is something that comes up, plus that it's also not harmful for you patients. Right, exactly, right again. So in our case, I mean how you get to the initial molecule can be different. In our specific case, the endocanneminoid system was discovered some thirty years some thirty plus years ago now, and it was discovered as one of the body's most important systems and to regulate basically all kinds of different processes in the body, specifically in the brain. And then some researchers, amongst which the researchers of our team, namely Professor Marcus Levica and Dr Catherine row leader, were amongst the pioneers to look into the endocindemonoid system with the specific intend to find out and to explore its potential to treat these kind of illnesses. So you have this system and you look into basically what it can do, and what they found is that there work surprising connections between dispalance us in the endocinemat system that...

...you can measure through different tests, and the presence of certain psychiatric symptoms. Specifically, and that's where we started, psychotic symptoms associated with with schizophrenia could be connected very strongly to a disbalance in the endocindement system. Hence the idea was developed to specifically target the endocinema system to treat schizophrenia. And again, we have to emphasize again that is not you just smoking joint and you're all well again, but this has some long term medical background, with research going back to the to the s in some of the cases. And why are you guys looking for psychiatric conditions? Why are you not developing like another cancer treatment? I mean there's there's several reasons for that and I think that the endocinema system has a huge potential that I don't want to exclude any specific indication from. However, our background is in neurology and psychiatry and we also think that this is an area which was neglected, or which was neglected as maybe a strong word, which was not treated with the attention that it deserved in terms of research effort and research money and research resources over the past decades really, and we see that the endocindamic system is specifically strongly in strong in the brain. So the effect that you can have by targeting the endocinomic system specifically strong in the brain. And so the sort the connection between psychiatric and neuropsychiatric indications and the endocinomic system is fairly natural, fairly clear. And also we have to just say that the background of our research has lies and psychiatry and neurology, and that's where they found sort of one of the strongest connections between using the endocindomal system and treating these kind of indications for which current medication, quite frankly speaking, does not offer a very attractive treatment options. I see. So basically they had a background in psychiatry and they've been digging through, like you said, molecules, substances and research what maybe the potential treatments of, as he said, some of the symptoms. It's not like a switch, but it can treat some of the symptoms, right, and how would be interested? How did this happened? That basically startup company, Lack Sanity Group joined up with the research group. I mean that's something you usually don't...

...have happened all the time, right, and that's very right, but sort of let me just stack the take one step back for the first part of your question, which was our our research team basically has a huge amount of experience in treating these kind of indications from a clinical perspective. So Professor Livid and namely is a psychiatrist in the first place and treated hundreds of patients presenting psychotic symptoms or are that are dear diagnosed with schizophrenia. And so what happened is that you take basically several kinds of samples from these patients. We're talking about blood and liquear from the brain, and you check the blood and liquwar force what we call bio markers, so for certain Marcus, for certain indications, and use tried to establish something like a correlation or a connection between the two. And, as I've explained before, with psychotic symptoms and the endocindemonte system and levels of the endocannemnotes, there was a very strong connection that could be established and that was really the basis for the development. And then the team from of researchers pushed the development of overcompound for the treatment of schizophrenia from the university. They try to work with public grants, with publicly available money, with money from the university, but the development of new drugs is very, very, very expensive. So while they were able to go through the preclinical stage, through phase one of the clinical trials and even into phase two, they are not able, on these kind of fundings, to continue the development through phase two and specifically phase three. So at a certain point they looked for partners that were able to give them infrastructure and funding in order to take the next step in the development, and that's really where we came into play, and we there were several other companies and partners that they had talks with, but we were really one of their preferred options. And I might add that big farmer, the classical farmer industry, is not really active in the field as of right now. I see that there's very interesting. So basically they reached the end of what the researchers could do with their funding situation and then they basically look for talks and talk to you and you to be the best match. You talked about like stage, stage one, stage two, phase one, face two, face three, trials. Can you explain us a little bit what that actually is, because my understanding is through a...

...few people, then more people, than more people, and at want point you have to end over most of the data to the authorities in charge, which means you kind of have to Redo most of the stuff several times. Right. Basically, yes, so what you're what you have to establish for people, for the regulatory authorities to give you the permission to sell your product, is you have to establish that your product is safe and you have to establish that your product works. That's basically it. So what happens? Is that? So, first, what you've mentioned before with all the animal and tissue tasting testing, what you do is you get indications, you see that the animals are not dying by the hundreds just by touching the compound. You see that, you obviously test the reaction of several these kind of animals or the tissue to the compound, and then you the phase one trials are really you test the compound on healthy humans. So the first thing you do is you ask people, often that works against the compensation, if they are ready to test your product and report how they were feeling, whether they've experienced any kind of discomfort or side effects. If that established that your product is safe and that the side effects were minor or limited, then you go into the next ways where you treat affect that people, so ill people, but you don't treat a huge number of them. The reason for that is that, basically two reasons. One reason is that ethically you don't want to subject people that needs treatment to a treatment that is not yet established to help them properly. And secondly, it established more safety data. And on the third side also it is a big economical risk to start these trials. So what you want to have some sort of a proof of concept alm also to speak. So you want to have more comfort and starting these very, very expensive phase three trials. So you do smaller trials before to get the first set of data and to see whether it works and whether it's worth it to pursue it in the phase three trial. And basically phase three is everything. Phase three is you look at the side effect, you look at efficacy and you have to show that your product helps people. Basically, M I see and my understanding is with what you have right now, the compounds, molecules that are helping to treat some of the schizophrenia symptoms. You are entering right now face two, which means clinical tries of sick patients. Right. Yes, well,...

...to be precise, we are already in face two. So what have happened is that even in phase two you can have different trials, and what we've had so far as we had very small, early stage phase two trials where we've already treated sick patients, but the number of patient is fairly limited, so we're talking about dozens of people and not hundreds of people like late stage shace to. And with these small stage phase two trials we had very good data coming out of them. So we showed basically, or what what the data showed, is that the treatment with our compound is at least as effective as a very common generation to antipsychotic. Sort of that's the standard of Care Right now. So it's least as effective, but it has almost no side effects, and that's really huge different because these antipsychotics for treatment of schizophrenia are amongst the drugs with the heaviest side effect profile amongst psychiatric drugs. Right. So you have you have problems with gaining a lot of weight, problems with, I'm sexual function, in terms of if males take it, you have problems with motoric functions. You can all have all these kind of side effects. And with antipsychotics it's not one of tenzero people, it's basically ten of a hundred people. So it's it's what we called a heavy side effect profile and if we are able to develop a drug that can help patient to the same degree but without subjecting them to these heavy side effects, that would be a huge game changer for a lot of people affected by these indications. Would that mean you help them to live a more normal life? Absolutely yes, that would mean that. Right now, you have to understand how debilitating schizophrenia is as a disease or as a mental illness, and it's it's certainly possible and and and manageable to live with it, but it's very tough. But the choice is a really hard one because the symptoms are really debilitating, but so is the treatment in a certain way, and currently available treatment we have really the choice of okay, I have these symptoms that are really really hindering me in my life, but if I if I do the treatment, if I take the drugs, I might have these heavy side effects that also affect and impair my life significantly. I mean there is no question that in a lot of cases, on most cases, currently available treatment is still much,...

...much better and preferable to not treating it metically. However, the side effect profile, as I've already pointed out, is quite heavy and this is why we are really trying to develop something to help people have a better life. And what numbers are we talk about how many people, like in the presented, in an absolute number, are affected by that level of schizophrenia. So, like with all statistics, there is there is a range that people estimate, but the lower side of the range estimates that about one percent of the population as affected by it. That means that about seven to about eight million people in Germany, about seventy seven million people worldwide are affected by schizophrenia at any given time. And also usually it is something that you struggle with for a long period of time, if not for the rest of your life. So it's something that's manageable but rarely surable at the moment. But that sounds like something a lot of really money, which farmer companies would jump on. Is that the case? Unfortunately, that is the case, yes, and I to a certain extent I understand the rationality kind that and that's really the reason also why we had the opportunity to jump on it. So let me first tackle why, in my opinion, a lot of farmer companies are not it's not top of their list to develop drugs in that field. It has something to do with to develop drugs is extremely expensive. We talking hundreds of millions of euros per drug. At the same time, with every drug you develop, the likelihood of it, when you start developing it, that it gets ever commercializized is limited. So we're talking about ten percent, in some cases less, when you start developing it. Obviously you spend money and you make progress and the likelihood is a little bit higher at the end, but it's still limited. Unfortunately, with psychiatric indications the likelihood of success is fairly low compared to other diseases. At the same time, unfortunately, in our society, psychiatric conditions are still not viewed in the same way as other conditions, although they impact and impair society, at least to the same degree. So you have a big disbalance between how, for instance, we see illnesses such as cancer or other sort of more common, more tangible illnesses and then and a mental disorders such as depression, schizophrenia or something like that is...

...something that a lot of people can really not imagine and it's much less tangible than a tumor, for instance. And that really goes into the second part of the question, which is why is it less likely to be successful with the development of a psychiatric drug? It is because it is much harder to measure and therefore much harder to show that it works. So if you imagine it, and this is a gross simplification. So anyone of the scientific community, please excuse the degree of simplification that I'm doing if worried that they used to that we need to simplify just for the very simple reason you cannot show a lot of graphics in with most people consume as an audio podcast simply doesn't work the very sorry. If you have something to correct, right, mean email. And so if you, let's say you develop something against cancer, let's say develop something against a brain tumor, right, so somebody is diagnosed, sadly, with a brain tumor and you want to treat it with a new drug. The brain tumor has a certain size. And now let's say that your claim is either we make it not grow or we make it even shrink. So what you do is you treat the patients and at the end of the treatment you take a ruler, you put it next to the tumor, on next to the image of the tumor and you measure and if it didn't grow or a trunk, you were successful. Right. This is a gross simplification, but it's something that you can imagine. If now the symptoms we're talking about are always subjectively measured. It is measured through I ask my patient how he feels, I ask my patient certain things. It is, I think, quite easy to imagine that this is much easier, a much harder to get objectively right or objectively wrong. And also degree is much harder to measure. So if we talk about depression, and again this is a gross simplification, do I ask you how much present do you feel better? Are you feeling better ten percent? Are you feeling better twenty percent? This is very hard to get exactly right. So obviously that the degree of sophistication with the question is much better and there are ways to measure it, but I think it's quite understandable how it can be much harder to get an objective response on the question whether a treatment is successful or not, and that, in the combination, is to the fact if you spend hundreds of millions of dollars as a pharmacytical company on the development of a drug, you will take the indications with the highest possible likelihood of a successful outcome. And that's the...

...reason why. That's some of the reason. I don't want to presume that I know everything, that some of them reason why I think that large pharmaceutical still shy away a little bit from developments in that field and that's the reason I think that there is an opportunity for small companies, for startup companies, which is, I agree with you, a little bit unusual right. But there is an opportunity for companies like Sanity Group to partner up with researchers and to try to find efficient ways of thinking of decision making processes, of linen structures, to try to not only sort of limit overhead and costs and the development and make it a little bit more manageable, but also to go into niches that are not dominated so heavily by the large corporations. HMM, I see. So that's basically the main reasoning you guys are doing it. We've heard you're now in state two tries whether the next step. You shared with me a quite amazing article by German publication called Business Punk. Actually I really like the picture of you guys on front of it and and they say, are you want to have your medication ready by twenty twenty five? I'm going at the steps until they're two thousand and twenty five is certainly very, very ambitious. I think that two thousand and twenty six is more realistic at this stage. I think that what we said is that we would be done with the clinical research in two thousand and twenty five, and then it really depends on how quick the regulatory bodies are in order to achieve commercialization in the markets. The next steps is to finish phase two trials, so this will take another twelve to eighteen months, and then to move into phase three. It is possible to start phase three even before you fully finished phase two, however, without wanting to go into detail and then sort of shorten the timeline by that. But the normal calls of action is finished phase two and then move into phase three. And what what? We are still open and we are sort of exploring the best pathway forward is with the question of how will we move forward after phase two is completed? Will we partner up with a larger pharmaceutical company in order to do the phase three together and have a partner right away to do the commercialization effort, or will we try to push through the phase three ourselves and and only seek partners potentially after that? That's still open...

...and that's, I think, the decision that we don't need to take right now, but we can take once we have more clarity towards space two and once we have more data on the running face to trials. Sounds like you have to decide either to do to yourself after face two and raise something like I do believe it goes into the hundreds of millions that you need then, or, on the other hand, partner with a big partner, for example, not related to any stages, but for example, as Biontech did it with Fisa for the corona vaccine. They also worked on production, distribution and stuff like that. We're not there to decide if, but if you could wish for something how the next few years would develop, what would it be? I mean, to be honest, there is a lot of passion and and and and work that we put into this and are still put it going to put into it until the face to two is completed. So we would love to stay involved even after phase too, and to stay on board until commercialization and after. So the third course of action, which I did coincidentally, didn't even mention, was to just sell off the asset after face too. It would pain me a lot to do that, and so I think that the entire team would prefer to stay on board and, in one form or another, continue to develop the medication. And I think it's almost unrealistic to think that we could do commercialization ourselves, because we're talking about such a vast market and such a big territory and in the entire world to say that to have the structures to be able to do that is really unrealistic and it's not even we don't even want to achieve that. So we would like to at some point partner with a larger corporation that is able to do the distribution and the production for and with us. At what stage specifically we do that is something, I think, that I don't even have to wish for right now, because I just wish for this product to be successful and to help people, and I really mean that and if I can contribute to that, I'm very happy and very proud of this achievement. And until then, there's so much and there's such a big hurdle to overcome that I think I want to take one step at a time and to really think, okay, let's get the face too done. Let's see if the data confirmed the very positive data of the early stage face to trials, and if that's the case,...

...then we'll take it from there. We'll have a lot of options down there. But I want to mention something else is that we also have other compounds in our pipeline. So this is the first compound and this is the compound that's most advanced, but we have other compounds based on other molecules in our pipeline that treat similar indications, such as social anxiety disorder or post traumatic stress disorder, which are also indications which are very big but for which the currently available medication is not really, I will want, not really ideal, let's put it that way, and to also push the development indeed of these compounds into a phase one or potentially face to something else that we are focusing on right now, so that we're really trying to get closer to our vision to use the potential of the Endocin emote system more broadly towards such indications. MM, that sounds pretty promising. That also sounds like you guys are currently on a hiring squeet too, in large you team. What type of people would you be looking for, because usually the answer is developers, developers, developers, says people. Say Spence, says people, but I do expect a little bit different answer from you guys. Well, I think I would first start with saying hiring spree is maybe not the right word for us, because one of the one of the things that we're really looking for is to keep our company lean in terms of people, because we want the money that we have to go into the development and into the further research of the endocainement system and thro the compounds. So yes, we are hiring. We are looking for pharmacists, we're looking for experienced managers of clinical trials that can be pharmacist, that can be doctors, and we are doing that, but it's it's a manageable amount of people that we're looking to hire. Let me put it away and basically everybody who knows how to deal with chemicals in the human body and around the human body. Yes, and how to deal with clinical research specifically and the regulatory bodies that are associated with it, because, as you might imagine, that the regulatory framework of doing these trials is fairly complex and it's important to know your way around these authorities, such as everybody has heard this acronym FDA or Ema in Europe. M MMM, I see. That's basically, and understatement, pretty complex and I would have one more question before...

...we could close this interview. Are you guys, because there's not yet a final decision made, will you will do in the future, but you guys are still open to talk to some interested investors? Right? Absolutely, as a matter of fact, we are currently approaching selected investors because the company, although it's a joint venture with sanity group, it was always set up in a way that allowed external, third party investors to come in, basically for two reasons. First off, well, it's very expensive and sanity group won't enter a certain extent can't finance the development until the end of phase three, and also, this is a very specialized field and it's a huge value add to have investors that know what they're doing, that have contacts and the field, that have experience with these kind of projects, so called smart money, to have smart money on board in order to go into the next stage of development, and I think that the investors we're looking for a usually specialized, because it is a very specific type of risk that these investors are getting in, because not only are we a start up, but we are start up in the field where the likelihood of success is linked to a lot of factors that we cannot influence without work. But there are investors that are specialized to do that, and the the upside potential is obviously very big. As of Right now, the valuation of such a company is still manageable, whereas if one of these compounds were to be successful, then we're talking about a very, very different valuation, and don't ask me what it is because I'm not going to comment on that too bad. Will be my last question. Well, next so far. Thank you very much. Everybody would like to learn more. We will link down here in the show notes. You're linked in profile, as well as the interview within, by the way, just between you and me, and something like Fifteenzero people listening to this interview. How is it to work with him? I mean I really like it, but we also have a we're on the same way wavelengths with a lot of things and we work super closely together. So I think I really like it, but I think it's not for everybody. I see, and of course we linked the interview with thin down here in the show notes. You linked in profile, website interview. Fin Yes, I mentioned everything also. Thank you very much. It was a pleasure talking to you. Thanks the pleasures all man, have a good day. By bye, bye, bye.

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