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Gregory D. Gorgas, President and CEO, explains what pharmaceuticals his company is developing to work with the body’s endocannabinoid system.
He touches on
Mr. Gorgas begins with how Dr. Raphael Mechoulam discovered our endocannabinoid system in Israel as he researched the effects of cannabis, trying to pinpoint what receptors it targeted. This allowed him to identify several receptors in our body, discovering this powerful system. Mr. Gorgas explains that the body makes chemicals that target these receptors and the cannabis plant mimics what the body already makes.
He then discusses why his company is working on pharmaceuticals to address this system. He says that it’s a powerful communication system throughout the body and handles responses to inflammation, stress, and any stimulus which the body would want to address. When the body is overwhelmed, introducing a chemical from outside the body may help this system.
He then explains the three ways Artelo Biosciences is trying to target this system through pharmaceuticals: First, a naturally-occurring cannabinoid that’s been altered to increase appetite yet avoid the euphoria or high state as a treatment for cancer patients; second, a cannabinoid called EBD with anti-anxiety and anti-inflammatory properties; and third, a fatty-acid binding protein-5 inhibitor originally researched as a cancer treatment.
For more, see their web site at http://artelobio.com/.
Richard Jacobs: Hello, this is Richard Jacobs with the Finding Genius podcast. My guest today is Gregory Gorgas. He’s the president and CEO of Artelo Biosciences. The website is A-R-T -E –L-O-B-I-O.com. And we’re going to talking about modulating the endocannabinoid system, which we’ll get into. So Greg, thanks for coming.
Gregory D. Gorgas: Well, it’s great to be with you today, Rich.
Richard Jacobs: Yeah. So what is the endocannabinoid system in people? What does it do? And cannabinoid sounds related to a hemp bender, you know, marijuana.
Gregory D. Gorgas: Absolutely. Happy to answer that question. And in fact, even though I had 30 years of biopharmaceutical drug development before initiating or starting Atelo, it was a new term to me. I had obviously heard of cannabis or cannabinoids, but really understanding this endocannabinoid system was in the field for me. And that’s part of the excitement that I had actually in helping found the company because you and I were born with an endocannabinoid system. Our endocannabinoid system presumably has been functioning well for us. And when I read a quote that the NIH said in 2013 that this modulation of this endocannabinoid system could affect a wide range of diseases. And when I read the extensive list of that wide range of, I was so impressed and I said, there’s a treasure trove of drug development opportunity based upon modular, fact, I put their quote up on our website. It was so Seminole. This endocannabinoid system is a family of receptors and neurotransmitters that form bile, a chemical communication network throughout your body, and do regulate things such as sleep that has an impact on fertility, some immune functions, and regulates a lot of biological processes including impact on anxiety and things of that nature. So I really thought there’s a drug development opportunity here. It’s an untapped potential. And I became very enthusiastic about modulating this endocrine.
Richard Jacobs: Well, that’s what I was going to ask you. What modulates it preferentially you know, naturally what did we encounter that modulating the system? What kind of substances or foods?
Gregory D. Gorgas: I appreciate you bringing that up, Rich. So this endocannabinoid system was first identified by Dr. Raphael Mechoulam in Israel and about three decades ago. And what he was trying to find out is on when someone ingests cannabis or takes partakes in cannabis, what receptors are being affected in the body. And so when he found these receptors that what’s led him to discover this powerful system throughout the body, but that system did not exist in original for cannabis. That the system exists because your body makes its own self-made chemicals. We call them endocannabinoid or self-made cannabinoid. The target these receptors of the endocannabinoid. And it just so happens that the plant mimics what your body already makes and can exogenously or from outside the body affect what your body’s trying to do for itself.
Richard Jacobs: That makes sense. Okay. I mean, I guess that’s a common mechanism. That’s how viruses and bacteria and foods and plants and all that affect people or other creatures. So they somehow know that.
Gregory D. Gorgas: Well it’s not unusual to think that something taken in from outside the body would affect one of the body’s natural systems. In fact, that’s exactly what’s happening. And so we call it the endocannabinoid system, partly because Dr. Mechoulam was thinking about where does cannabis or cannabinoids these chemicals that come out of cannabis target throughout the body. But it was then discovered that your body makes its own self-made cannabinoid
Richard Jacobs: What physiological circumstances does your body make the endocannabinoids and when they do hit the receptors, what does that do for you?
Gregory D. Gorgas: Well again, it’s a powerful communication system throughout your body and it’s usually as a response to inflammation or stress anxiety or some external stimulus that is for which our body would naturally want to have a defense against or address in some positive way. And that’s the body’s own system that would address that. Sometimes that system gets overwhelmed and that’s where we think about delivering a chemical from outside the body to assist the body in dealing with that stress or stimulus that’s outside the box. The unique aspect of our company Artelo Biosciences is that we are a full spectrum endocannabinoid modulating company. Meaning that when I went out to learn about this system, I found that researchers, well reputable reads from universities and places throughout the world. We’re targeting three ways to modulate this endocrine health and that was to deliver naturally occurring cannabinoids or chemicals that come from. And that would be one that everybody would sort of easily put their mind around it and understand. But the pharmaceutical industry has been making chemicals for many, many years that can either mimic or can target the receptors of the endocannabinoids. And third, there are ways through protein inhibition that regulate exactly what your body’s doing. Perhaps, maybe efficiently in certain circles. And we are the only company, to my knowledge, that has a naturally occurring cannabinoid development program, a synthetic or small molecule that is rationally designed that targets the end of the receptors and a protein inhibitor called a fatty acid-binding protein five inhibitor that helps regulate and modulator lipid signal and regulate endocannabinoids.
Richard Jacobs: Well, how many different phenomenons are there, and what’s the difference in function with one binds versus another?
Gregory D. Gorgas: Well when we look at the endocannabinoid system and in a very simplistic way, I’ll just share that you can think of an on switch or an off switch or an agonist or antagonist receptors. And there are well over a hundred different chemicals that have been identified out of the cannabis plant. So there’s in some reports 113, and that’s oftentimes a number that’s quoted on the internet, but some yet to be discovered or well-characterized. But there may be as up to 600 different chemicals that can be identified out of the cannabis. Principally, when we think about therapeutics today, then we’re thinking about two chemicals outside the body and that’s cannabidiol or THC. And those are two chemicals that have been identified out of the cannabis plant. Internally to the body the endocannabinoids, the two principal ones are anandamide and 2ag. And these two chemicals are analogous to THC.
Richard Jacobs: What happens if you take a CBD or if you take what’s supposedly a full spectrum type product? Are they really full spectrum according to like you’re testing what you’ve seen out there and depending on the mix of endocannabinoids that you provide to somebody, a few small molecules or through natural products, what can you modulate? What is it your goal to modulator you coming out with a suite of products for certain purposes?
Gregory D. Gorgas: Yeah, I appreciate that Rich. So again, we have three programs in development and I can’t necessarily speak to the development programs that others have, but I’m very familiar with ours. So if I might share with you, one of our programs at a small molecule that was originally identified at AstraZeneca through a screen of about 75,000 compounds. And this a mechanism, very similar to THC in that it is believed to be responsible for as an agonist, as a full agonist to the C1 and the receptors, the main receptors and by the way, THC to partial agonist and as a full agonist, that wouldn’t be surprising that we have tremendous appetite stimulation or with our drug and it’s been in five-phase one studies 200 when regulated drug development studies.
And so we know the profile of the drug. So we know that it has a profound impact on an appetite stimulant. But the beauty of our drug, as opposed to THC, is that it does not target the receptor in the brain. It avoids the central. And so you will avoid the euphoria or the high, and I’m not speaking about where there might be an attraction to THC, the recreational endpoint, but certainly from the medicinal perspective, if you’re looking to stimulate appetite and you want to avoid the euphoria or the high while the sick and they’re going cancer, then, in fact, the profile of our drug, we considered superior because you can get all the medicinal benefit, let’s say for appetite stimulant from the gut region. This stimulates appetite below the neck and not the psychoactivity above the next. So that would be one compare or contrast that we would have with our compound versus something that’s isolated or extracted from the cannabis plant. And so real elegant opportunity I would say from Artelo Biosciences for that. But the condition and where we’re applying that I might just continue to add where we’re applying that is where we a big unmet need. Anorexia, cancer, I don’t know if you know this, but six out of every 10 late-stage cancer people suffer from profound anorexia that contributes to their demise are wasted.
Richard Jacobs: Yeah. Cachexia I guess, right?
Gregory D. Gorgas: Yeah. Cachexia is the muscle waste. Anorexia is appetite loss and weight loss. But if we can return that appetite and have people participate with their families, participate in their drug therapy or biological therapy and we can help them have a functioning body so that they’re making work better, we impact not only on their wellbeing but maybe eventually an app increase longevity. We’ll have to wait and see how the data bear out on that. But we do know that folks that are able to maintain their weight tend to live longer than suffer.
Richard Jacobs: Yeah. Well in the market, I mean you have a lot of purveyors and they’re making all kinds of claims. I can see that you’re staying in a very different part of the market. You know, more medical side and the application you’re going for is great. The cancer patients definitely need all the help they can get. Anorexic people who, when you survey though the current market and the current claims and products, where else do you see an opportunity to really help people in addition to what you’re doing?
Gregory D. Gorgas: Well, so that’s one area with one of our assets and that’s our telo2713, which we have going into a safety lead into a phase two study in cancer, anorexia and we’re very excited about the data there. But we have two other development programs. One of them is a naturally occurring cannabinoid known EBD and EBD is very attractive for its known anti-anxiety and anti-inflammatory properties. And in fact, there is a regulatory pathway that has been paid by GBU pharmaceuticals because in June of 2018 their C product called up dialects was approved to a rare form of childhood epilepsy and the only active ingredient or compound. So there’s a lot of reasons to like but we looked at CD though and said, could we get better? We believe we have addressed some of the limitations to and have made a more pharmaceutically elegant compound in a solid form. And in fact, we applied for a patent and in March of this year we received it. The first and only issued patent on the composition of CNET gives us protection, develops this compound in December of 2038. And what’s important for that is not only do we have a superior compound and the FDA will eventually be the arbitrator of whether it’s safe and more efficacious but from the elegance that we built in, we know it’s more stable, believe it’s going to be NITSA absorption.
And what we’ve done, we’ve taken the inherent differences in the different shapes of the naturally occurring CD and turn it into a single shape which delivers back and forth.
And then with a patent protected compound, we’re able to go in and develop it for diseases such an inflammatory bowel disease or for symptoms of that are associated with PTSD for the anxiety or sleeplessness but in contrast to over the counter or CBD that someone might be able to take. We have made a far more pharmaceutically elegant product that will have more consistent delivery. And in the presence of drug-drug interaction from emerging and known through the code administration with other drugs, we believe we’re going to have an edge for physicians who make decisions on giving us the product. So we’re pretty excited about the pharmaceutical elegance that Artelo is leading with our version.
Richard Jacobs: Yeah. And you also distance yourself even further from anything that could or could not happen with natural CBD products.
Gregory D. Gorgas: Yeah and again, we believe there’s room for both. There may be some CBD as people have taken for non-serious or life-threatening conditions over the counter. And I have family members that do that and I’m supportive of those activities to the extent that their state allows for it and they and their physician or their election. That makes sense. But for serious and life-threatening conditions such as epilepsy or schizophrenia or Perkins or inflammatory bowel to CPS. These are conditions in which there’s often a co-administration of another drug and the pharmaceutical elegance that Artelo has with our product, I think plus the consistency and purity and the ability to trust the compound that the FDA has reviewed and saying is safe and efficacious.
Richard Jacobs: Once the endocannabinoid binds, what clears it from a receptor, and why?
Gregory D. Gorgas: That’s a science question that is above the CEO’s pay grade. And I would have to defer to some of the scientists, some of the leading endocannabinoid specialists on our, we have a professor of cannabinoid research, Dr. Saoirse O’Sullivan came out of the UT of Nottingham. We have another PhD scientist, Dr. Andy Yates that got his PhD at the University of Nottingham and is a registered pharmacist in the UK. These are some of the experts that are advisors. I’ve never asked them that question so I can’t answer that question of your audience, but I’m happy to get back to you on a separate podcast someday.
Richard Jacobs: You should ask them later and they’ll say, who told you that?
Gregory D. Gorgas: They will and they’ll say that’s something you should know. But we stay on the top of regulated drug development. I think that can help.
Richard Jacobs: No problem. No problem. Well, the reason why I ask is you mentioned protein inhibitors. I don’t know their role that’s even relevant but go ahead.
Gregory D. Gorgas: Yes, very specifically. When anandamide one of your self-made cannabinoids comes inside of your cell. There is a protein called the fatty acid-binding protein. In our case number five, your body has nine of them. Number five will chaperone that anandamide saying you don’t belong here inside the cell and we’ll take it to a lipase or a hydrolase called fatty acid might hydraulics and we’ll destroy the anandamide. So what there was a belief that if we can then and the NIH gave about $4 million in research money to Stony Brook University in New York to help them develop an inhibitor to this fatty acid-binding protein five so that you would never chaperone that for destruction and thereby allow the accumulation of this anandamide in the body to deal with things such as inflammation and pain. The data looked very, very interesting from a clean preclinical perspective that Stony Brook developed on the back again of NIH and their own research initiative. And so that protein inhibitor looks very, very interesting for helping regulate the body’s own endocannabinoids in situations of pain. And what we also saw is that this fatty acid-binding protein five as part of a signaling mechanism for fatty acids that would go to the nuclear receptor and stimulate a vascular endothelial growth factor that would help in angiogenesis or the formation of new blood vessels and it stimulates the growth and migration of cancer. And interrupting that signaling mechanism appears to have a very profound effect when in situations where fatty acid-binding protein five appears to be up-regulated and that’s in breast and prostate cancer.
And when we saw that data, either alone or in combination with the standard of care in preclinical research, we said that is the first and highest priority of the company to develop in a cancer space. And so that’s what we’ve done with that third program. So again, as a full spectrum company, we have the synthetic irrationally designed small molecule that targets as a full agonist. The cannabinoid one, cannabinoid two receptors, we have a naturally occurring cannabinoid called cannabidiol that we have made pharmaceutically more elegant. And we believe that eventually, that is going to lead to superior data in efficacy and safety in the regulated drug development for important diseases. And then this third asset that we have, the fatty acid-binding protein five inhibitor. Initially, we’re developing that as part of the lipid signal for cancer. But it has growth and upside opportunity as an anti-inflammatory and as an anti-pain drug. And we’re excited to see where the data will take us with that third app.
Richard Jacobs: Yeah, because some of the uses of your products will be for a life-threatening illness. Is there a fast track to get approval to get through clinical trials? Do they get sent to the market soon?
Gregory D. Gorgas: Yes, there may be. And we have not yet applied for that. So I can’t say that we have a fast track status, but these are important assets within the company and we will use every regulatory advantage, what we can as we move forward in diseases if that is in rare and orphan diseases, we’ll apply for orphan drug status. And if it is enlarged and major for which we have breakthrough status or fast track, we’ll apply for a concession.
Richard Jacobs: Yeah. Maybe if it is eligible for compassionate use or a bunch of vet strike options. Just what came to mind.
Gregory D. Gorgas: Absolutely. We’re excited about what we can accomplish with all three of these things.
Richard Jacobs: Is there any consideration of the effects on men versus women or by age or what about the microbiome? I mean, you may not know, but because the endocannabinoid system is so pervasive and important in the human body, there’s probably a microbiome effect, depending on the state of someone’s microbiome. So are you able to look at that or is there just too much to look at and consider even with what you’re doing?
Gregory D. Gorgas: We don’t have any data to date to suggest any of our assets work in one gender versus another or any specific aspects of that. So, for example, hormone-driven cancers, for example, with our fatty acid-binding protein five inhibitor two come to mind. One is prostate cancer, one is breast cancer. And I know that men can have breast cancer more often than women. And so in both of these hormonally driven cancers, it looks like our drug would be applied depending on what type of with respect to CBD, I’m not aware of any specific gender-based differences in what the drug is likely to the treatment effect. There may be and it’s just outside of my knowledge.
Richard Jacobs: Yeah, I just mentioned it because I never hear of drugs being developed that consider the hormonal cycle of women or the hormonal status of a person or again, as I said, it appears that the microbiome appears to modulate a lot of conditions. So I guess there’s only so much you can consider, but I just wondered if there’s any data on that that you’re looking at or that you know, not,
Gregory D. Gorgas: Yeah, as I said, I don’t have any specific data on one of our drugs applying to female versus male.
Richard Jacobs: Okay. What’s to come in the next year or a couple of years? What’s the product is the nearest completion, nearest approval?
Gregory D. Gorgas: Well, in our hands, the drug for the full agonist to the cannabinoid one and cannabinoid two receptors, that’s our lead clinical program. And that is going through a safety lead-in, 18 people. And then it’ll go into a randomized phase two study and then it’s just one click away. Maybe one or two studies in phase three or pivotal studies that we could bring to the FDA or EMA in Europe or the MHR in the UK to seek regulatory approval. So for us, that’s the lead development program. That’s the nearest coming to the market. Our earlier-stage programs are preclinical in nature and we’re aiming to throughout this year and next year, do the regulatory studies so that we can have that into the clinic in early 2022 or late 2021. And then it’ll go through a normal drug development process. It’s too early to tell at this point in time. And it would be false precision to offer how many years that may take and whether it would have breakthrough status and what indications and how big the studies are. It just is not something that we would understand at this point in time, but generally, that process takes anywhere from five to seven years before the drug gets eventually.
Richard Jacobs: And no problem. What’s the best way for listeners to keep track of your progress?
Gregory D. Gorgas: Well, we do have a website, artelobio.com, A-R-T-E-L-O-B-I-O.com. And that’s one way to keep track of our progress.
We typically keep a current corporate presentation online. There are several videos that have me or one of our scientists explaining our development programs. And those videos are available under the media tab. We are a public company. We are on the NASDAQ and so current and all of our filings. And so one could look up under the SEC or a convenient link on the investor’s page of our website to all of our public filings. And then that’s where people also keep track of the progress.
Richard Jacobs: Very good. Well, Greg, thanks for coming on and sounds like this will be a fantastic suite of products when they’re ready. So I appreciate you here.
Gregory D. Gorgas: We’re excited about this. When I first learned about the endocannabinoid system, one of the things I had to do was weave between misperceptions and misinformation in my research and it was really nice to see eventually that one could really get a clear understanding of the endocannabinoid system that the people now that are associated with developing pharmaceuticals that’s experience is maturing. The data is maturing. And I think that if we look towards the future we’re going to be talking less about the mechanism and we’re going to have these as mainstream opportunities for us. We’ll have more product approvals because the pipeline is filled not only with our compounds but other companies that are of a similar focus. And I think that companies like ourselves that are part of the land grab someone has said, what do you feel like today? I said, I feel like Apple in the mid-eighties, and I feel like we’re grabbing intellectual property and we’re at the early stages, but I believe there’s very, very bright for companies like ours that have the vision and can anticipate the one can live and sort of learn from those that have paved the way before us. So thank you very much. Opportunity to share with you and again, if anybody wants to learn more about it it’s artelobio.com and we’re happy to have that conversation materials provide it out.
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