Transcription
Rafael Permuy Martínez 0:02
I'm Rafael Permuy, thank you very much for the invitation today, I don't know if you're aware is, especially for all of us, because is the Alzheimer's Day precisely, it's coincidence. It's very curious. We are focused on the neuroscience of space. And one of the main things that we have to bring to society is precisely to try to tackle neurodegenerative diseases, especially assignment one of the most one in terms of prevalence, no doubt, we'll have to tell you, how, how big is the impact from a social point of view, but also from an economic point of view, what is called the burden of disease that most of you are perfectly aware, right? And give it a thought, in the last 44 years, only four drugs has been approved in this particular disease to try to tackle this particular disease, or more than 100 in oncology, so it's clear and met medical needs. And everything has to be on most of it with the blood brain barrier that is specifically designed to protect us against toxics. But when you want to put a toxics, because a drug is a toxic itself, to try to help with certain disease, or this space, the Berberine is going to be against you is going to fight against the fact that you are working at. So in NeuroStech, we are trying to develop new ways of administration drugs at this space, okay, at intrathecal level, at this place where the drugs has to be placed in order to be effective. But the main issue here is that when you want to tackle these places, usually there are side effects, because of the autoimmune response of the body. We want to administrate the drugs from a different place, we are going to tackle the same space, but we are going to do it physically in another way. As you can see here, this is a small implantable device, obviously will be a class three, that is going to be implemented a Luma lever or displace. And it will be connected with intrathecal space with a dual lumen catheter, something the idea of putting catheters in contact with a intrathecal space that are doing currently companies such as Medtronic, for example, in the use of oncological drugs, to deliver morphine, okay to treat the pain, all these diseases that you can see here, the first one Alzheimer's, because today again is the Alzheimer world, they are in the same problem, the same origin of the disease, which is the overexpression of certain protein that is causing damage at brain level. So this concept, this approach, this new way of administering drugs, could be useful in combination with certain antibodies in all these different diseases, okay. Obviously, from my point of view, is well protected in most of the main countries or wide. And as you can see here, there are three different chambers, two different holes in order to put and remove the antibody that has to be placed. Because the important thing here is that inside the device, the antibody will remain the liquid with the protein, the toxic protein will come through the catheter. And inside the device, the antibody capture the protein, and the liquid remains leaves the device and goes to the intrathecal space and to the brain continuing with the fluid. And without pumps, electronic pumps, we don't have electronic pumps. So from a regulatory point of view, we expect a clearance ago, because it's it's already there in the market for some other indications where we are, we have some promising results in mice. Last year, we have a paper scientific paper with good results in terms of the concept and also from efficacy point of view even higher than expected. Remember, we don't expect to remove like it's from the brain, we want to stop the progression of the disease. But in this case even worse, promising and surprising the results potentially because of the size of the device, how it works. The liquid comes from here as I mentioned, these are the proteins enters through a nanoparticle chamber and the antibody retains the protein inside leaving the liquid to the N particle space. We are starting the trials pigs big animals with the same size design and materials that are going to be used afterwards at human level okay. So, everything that has to be with the surgery of the implementation of the device, the materials, the compatibility and so on, will be proved. And later we have to start with Doman beans, obviously, as you can see, here we are we are in the safety and feasibility study. Here we are with the pigs starting precisely this year. We need certain money, it depends on the ambition of the of the partners that we find in this in this in this way. Obviously, if I may, I would love to do both clinical trials in parallel in Europe and America from scratch from the very beginning, in order to have the approval as soon as possible in both markets. So potentially these figures between one 1.5 6 could be up to 10 Millions depending of the ambition that we share. As a summary, the take home message is clearly potential efficacy increases because of the dose that you can place in the in the device safer. Remember, the antibody remains in the device is not going to be a race is going to be there. So he sacked him, but he's not causing the side effects that unfortunately, some antibodies are causing in the clinical trials. An important thing when you have to change the antibody when you have to change the filter, because saturated it work enough is going to be due at primary care level, because it's just with a needle, we can remove the antibody or we can place it back, we don't need to go to the operating room again obviously, then it will be absolutely cost effective right. We have some other things in the pipeline. The dual lumen catheter itself will be combined with some other external elements to play a role in neurological conditions. In fact, there is an Italian multinational company already interested in this concept, but also we have some ideas with the membranes in order to help with advanced therapies to relate the training of this of these therapies right. Are we alone? No, luckily, we are not alone. But we have advantages. This one is not a competitor, this is only to illustrate that the idea of putting drugs in the intrathecal space is is already there since years right. And the idea of make a filtration of the CSF is also there there are many companies want basically are in Barcelona griefers, they have the study, they are doing exactly the same. But at the hospital level extracorporeal level the patient has to has to go to the hospital to receive the treatment, we are saying that the treatment lives with you 24/7, right. And there are some other American companies doing something similar relatively similar but with a different mechanism. We want the business model is particularly our for us currently, we don't have the resources to commercialize something so big, we are pretty conscious of our size, and our capabilities. So we are aiming to close a deal with a corporate partner in order to launch globally. Obviously, once the results are confirmed at human clinical trials level. By the way, anything is very typical, because the pharma industry looks as counting looks like earlier, right and early stages they are looking for for alternatives. So two of them are already interested. In fact, one of them paid for the International extension of the patent, I have to say, we are working in IPS strategy. And I have to tell you, this is the team myself, I'm in the corporate development world since 25 years, always looking for for new ways of selling things, business development, and now selling the project if I may, from the investor's community, but the scientific background of the thing is really huge. More than 10 years, specifically, in this particular project in this field, the company was built just two years ago, but based on more than seven years of basic research. Okay, this is part of our network at different levels, both nationally and internationally. And that's where we are we did this between, let's say 1.5 and 7 million depending on the ambition even higher a way we find the proper proper partners. As you can see here, this is the funding of 1 million. But could we today, thank you very much for your time precisely in a day like this is a coincidence but it's important help us to try to fight this complicated disease and all these neurodegenerative diseases. Thank you very much for the time
Innovative mindset professional with background as business director and access to market roles within different industries (Biotech, Pharma, Vaccines, Medical Devices, Consultancy) and markets (Spain, Portugal, UK, Italy, France, Latam, etc). Founder partner and senior entrepreneur adding business acumen to promising startups in biotech. Visiting Professor at Master in Biotechnology of Environment and Health at University of Oviedo (Spain).
Innovative mindset professional with background as business director and access to market roles within different industries (Biotech, Pharma, Vaccines, Medical Devices, Consultancy) and markets (Spain, Portugal, UK, Italy, France, Latam, etc). Founder partner and senior entrepreneur adding business acumen to promising startups in biotech. Visiting Professor at Master in Biotechnology of Environment and Health at University of Oviedo (Spain).
Transcription
Rafael Permuy Martínez 0:02
I'm Rafael Permuy, thank you very much for the invitation today, I don't know if you're aware is, especially for all of us, because is the Alzheimer's Day precisely, it's coincidence. It's very curious. We are focused on the neuroscience of space. And one of the main things that we have to bring to society is precisely to try to tackle neurodegenerative diseases, especially assignment one of the most one in terms of prevalence, no doubt, we'll have to tell you, how, how big is the impact from a social point of view, but also from an economic point of view, what is called the burden of disease that most of you are perfectly aware, right? And give it a thought, in the last 44 years, only four drugs has been approved in this particular disease to try to tackle this particular disease, or more than 100 in oncology, so it's clear and met medical needs. And everything has to be on most of it with the blood brain barrier that is specifically designed to protect us against toxics. But when you want to put a toxics, because a drug is a toxic itself, to try to help with certain disease, or this space, the Berberine is going to be against you is going to fight against the fact that you are working at. So in NeuroStech, we are trying to develop new ways of administration drugs at this space, okay, at intrathecal level, at this place where the drugs has to be placed in order to be effective. But the main issue here is that when you want to tackle these places, usually there are side effects, because of the autoimmune response of the body. We want to administrate the drugs from a different place, we are going to tackle the same space, but we are going to do it physically in another way. As you can see here, this is a small implantable device, obviously will be a class three, that is going to be implemented a Luma lever or displace. And it will be connected with intrathecal space with a dual lumen catheter, something the idea of putting catheters in contact with a intrathecal space that are doing currently companies such as Medtronic, for example, in the use of oncological drugs, to deliver morphine, okay to treat the pain, all these diseases that you can see here, the first one Alzheimer's, because today again is the Alzheimer world, they are in the same problem, the same origin of the disease, which is the overexpression of certain protein that is causing damage at brain level. So this concept, this approach, this new way of administering drugs, could be useful in combination with certain antibodies in all these different diseases, okay. Obviously, from my point of view, is well protected in most of the main countries or wide. And as you can see here, there are three different chambers, two different holes in order to put and remove the antibody that has to be placed. Because the important thing here is that inside the device, the antibody will remain the liquid with the protein, the toxic protein will come through the catheter. And inside the device, the antibody capture the protein, and the liquid remains leaves the device and goes to the intrathecal space and to the brain continuing with the fluid. And without pumps, electronic pumps, we don't have electronic pumps. So from a regulatory point of view, we expect a clearance ago, because it's it's already there in the market for some other indications where we are, we have some promising results in mice. Last year, we have a paper scientific paper with good results in terms of the concept and also from efficacy point of view even higher than expected. Remember, we don't expect to remove like it's from the brain, we want to stop the progression of the disease. But in this case even worse, promising and surprising the results potentially because of the size of the device, how it works. The liquid comes from here as I mentioned, these are the proteins enters through a nanoparticle chamber and the antibody retains the protein inside leaving the liquid to the N particle space. We are starting the trials pigs big animals with the same size design and materials that are going to be used afterwards at human level okay. So, everything that has to be with the surgery of the implementation of the device, the materials, the compatibility and so on, will be proved. And later we have to start with Doman beans, obviously, as you can see, here we are we are in the safety and feasibility study. Here we are with the pigs starting precisely this year. We need certain money, it depends on the ambition of the of the partners that we find in this in this in this way. Obviously, if I may, I would love to do both clinical trials in parallel in Europe and America from scratch from the very beginning, in order to have the approval as soon as possible in both markets. So potentially these figures between one 1.5 6 could be up to 10 Millions depending of the ambition that we share. As a summary, the take home message is clearly potential efficacy increases because of the dose that you can place in the in the device safer. Remember, the antibody remains in the device is not going to be a race is going to be there. So he sacked him, but he's not causing the side effects that unfortunately, some antibodies are causing in the clinical trials. An important thing when you have to change the antibody when you have to change the filter, because saturated it work enough is going to be due at primary care level, because it's just with a needle, we can remove the antibody or we can place it back, we don't need to go to the operating room again obviously, then it will be absolutely cost effective right. We have some other things in the pipeline. The dual lumen catheter itself will be combined with some other external elements to play a role in neurological conditions. In fact, there is an Italian multinational company already interested in this concept, but also we have some ideas with the membranes in order to help with advanced therapies to relate the training of this of these therapies right. Are we alone? No, luckily, we are not alone. But we have advantages. This one is not a competitor, this is only to illustrate that the idea of putting drugs in the intrathecal space is is already there since years right. And the idea of make a filtration of the CSF is also there there are many companies want basically are in Barcelona griefers, they have the study, they are doing exactly the same. But at the hospital level extracorporeal level the patient has to has to go to the hospital to receive the treatment, we are saying that the treatment lives with you 24/7, right. And there are some other American companies doing something similar relatively similar but with a different mechanism. We want the business model is particularly our for us currently, we don't have the resources to commercialize something so big, we are pretty conscious of our size, and our capabilities. So we are aiming to close a deal with a corporate partner in order to launch globally. Obviously, once the results are confirmed at human clinical trials level. By the way, anything is very typical, because the pharma industry looks as counting looks like earlier, right and early stages they are looking for for alternatives. So two of them are already interested. In fact, one of them paid for the International extension of the patent, I have to say, we are working in IPS strategy. And I have to tell you, this is the team myself, I'm in the corporate development world since 25 years, always looking for for new ways of selling things, business development, and now selling the project if I may, from the investor's community, but the scientific background of the thing is really huge. More than 10 years, specifically, in this particular project in this field, the company was built just two years ago, but based on more than seven years of basic research. Okay, this is part of our network at different levels, both nationally and internationally. And that's where we are we did this between, let's say 1.5 and 7 million depending on the ambition even higher a way we find the proper proper partners. As you can see here, this is the funding of 1 million. But could we today, thank you very much for your time precisely in a day like this is a coincidence but it's important help us to try to fight this complicated disease and all these neurodegenerative diseases. Thank you very much for the time
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