The ongoing opioid addiction epidemic in North America has been well-documented and many companies have been looking at ways to alleviate the issue through various methods.
One of those methods is through proven plant medicine, notably the use of Ibogaine, a naturally occurring psychoactive substance, which preliminary research has indicated may help counter drug addiction.
One company leading the charge is Vancouver, British Columbia-based Universal Ibogaine Inc., currently a privately-held pharma company, formed in 2018, which is looking to list on the TSX Venture Exchange via a qualifying transaction with P Squared Renewables Inc.
The company aims to submit a Clinical Trial Application to Health Canada to undertake clinical trials in Canada to prove the safety and efficacy of the use of ibogaine and, in the longer term, plans to introduce ibogaine into the addiction treatment protocols to be used by healthcare professionals, including in its future facilities.
Proactive sat down with Universal Ibogaine CEO Dr Rami Batal to find more about the substance, the company and its exciting plans.
Proactive: Universal Ibogaine is looking to address addiction highlighted by the opioids crisis, with Ibogaine being central to the company’s innovation. What exactly is ibogaine and how does it work?
Rami Batal: Ibogaine is a plant-derived medicine. It can be extracted from, among other plants, a tree in West Africa, in the Gabon specifically, called the Iboga. It has been a ceremonial plant in the Bwiti spiritual practices in that part of the world but is now sourced sustainably to ease any supply pressures.
Similar to many other medicines, the plant source of Ibogaine is something that is legitimate and accepted. Ibogaine can be derived from the bark of the root of the tree, and it is a medicine that works like nothing else that we currently have in the treatment of addiction.
It is not a substitution therapy - we're not trying to substitute one opioid for another when we talk about addiction treatment. Rather it has a particular unique pharmacology that breaks the addiction. It removes the craving, which is the starting point, usually, in the vicious cycle of craving, binge, remorse, and repeat.
Ibogaine works on a group of receptors in the brain. We call these drugs promiscuous, or broad-spectrum as they hit multiple receptors at the same time, like the reward system mediated by dopamine and others. It is also claimed to regrow the nerves, rewiring the brain in a certain way whereby the craving for the substance goes away. It doesn't go away forever, but it goes away for a sufficient amount of time - three months, six months - to give us a window of opportunity whereby the brain is fresh again. It's a pre-addiction brain that allows us to come in with all other modalities of treatment that had failed in the past because now suddenly Ibogaine has taken the brain to a point whereby it's receptive to everything else that we have. So it's really unique in how it works and we're really excited about working with it.
So how will you medicalize Ibogaine in Canada, and do you have competition?
We are going to go through the door, there's no other option. Ibogaine is a serious medicine that needs to be respected. It's a medicine that needs to be administered in a medical setting. It needs to be considered and sanctioned by the regulator. These regulators need to see Ibogaine, and they need to have us commit to what we call the high priest of evidence-based medicine, which are clinical trials – randomized, controlled and
double-blinded.
We're going to go in front of Canadian regulator Health Canada which we feel, based on conversations in the past, are very willing to listen. They understand the size of the problem, they understand the potential for Ibogaine. We're going to conduct a large human proof of concept study as we need to re-establish Ibogaine’s safety in the eyes of the Canadian regulator and we need to show its efficacy as well.
We are very confident that this is going to play out as we hope because of the history of utilization of Ibogaine in other jurisdictions where it has been shown to be efficacious and safe in the right hands, with the right administration.
After that big study, we’ll see. Some people say we might need to do other studies but by that point in time there will be a particular upside associated with the value of the drug and the company that is propagating it because we will have proven the principle. While others say, Health Canada and others, would be very much willing to consider something that would look like a special access program, whereby you start rolling it out to patients with additional vigilance to make sure that it's done in the right way as you continue your process. So we're very excited about this next step and we're very confident that we've chosen the right path to move forward.
As for any competition, I would call that more validation than anything else. We are part of a global community that is looking at Ibogaine, and the possibility of introducing it into medical practice. Some of them are academic, some of them are industrial, and we talk to them and we are going to help each other to get this through. Once you move a bit forward, then everybody starts innovating in a particular direction, and
they protect for themselves ‘a particular niche’. We're going to get to that stage, and we're confident this is going to be very good that way.
So is there data to support your assumptions about the safety and efficacy?
Again, that's the beauty of working with something that has been out in the community and in the environment for years. I mentioned that randomized, controlled and double-blinded clinical studies are the high priest of evidence-based-medicine, but they are not the sole form. There is also real-world data, and the history and literature that we have in and around Ibogaine since the 1980s. And of course, the old spiritual Bwiti ceremony in the Gabon gives us tons of validation as to the quality of this particular drug.
So when we go to Health Canada, we're not going to go and talk about our first experiment with mice or dogs or rats, we're going to go in with real human data.
Also, we have acquired the medical data, and the ibogaine safe administration protocol, of a clinic out of Mexico, the Clear Sky Recovery Clinic, that's been treating patients with Ibogaine for a decade. More than 3,500 treatments to date, that have been successful, that have been efficacious, that have been safe. And we're going to be able to utilize these data as part of our repertoire with the regulator. It’s never going to replace the clinical trial path but it's going to be very, very helpful.
So the company's path to going public involves the acquisition of the Kelburn Mental Health and Addiction Recovery Center, an addiction treatment facility near Winnipeg in Manitoba. What's significant about this property in your mission and vision?
Everything. What attracted me in particular to Universal Ibogaine is the dual platform of the business. On the one hand, you are developing medicines as if you're a biotech company, turning the Ibogaine platform into a legitimate authorized, widely accepted medicine for addiction.
But we also have this opportunity to actually be healthcare providers ourselves in an area of addiction that has been, from my initial observation, still living in the Medieval Ages. It's more artsy than it's a science. It's nowhere close to a sophisticated disease management system. If you're looking for example, at a benchmark like diabetes. There is nothing compared to the sophistication that we have in the screening, diagnosis treatment, long term management of diabetes when it comes to addition.
We have an opportunity here through this clinic as we get into treating addiction, to innovate. Not only in terms of ibogaine as a medicine, but also in terms of the operating model, the disease management model of addiction, the introduction of other regulated and authorized psychoactive (AKA psychedelic) substances through treatment. Ibogaine is the crown jewel but it is not the singular when it comes to addiction management. A sophisticated complex disease also requires sophisticated, multiple modalities, and we can do this through the clinic. So it's a great starting point. It's also an opportunity, given its size, to put a Research Park down the road, working with a close-by University, the University of Manitoba to research psychedelics. It's an opportunity to build that model and to roll it out into other clinics in our name.
So what initial number of clinics are envisaged in this network?
So that depends on what sort of clinics. For starters, we like clinics that have already been started, we think that there's going to be great opportunities to optimize them, so it's not going to be greenfield sites, let's say it's going to be brownfield. Now, the answer to the question depends on whether we're defining the clinic as a singular, or as a series of clinics that belong to a particular owner as we go about acquiring them.
The rest of this calendar year is going to be about optimizing the Kelburn clinic and building the operating model, the disease management model, the introduction of additional psychoactive substances, as we wait for ibogaine to be medicalized in our hands and then brought back to the clinic.
We would like to spend the rest of the year doing so. We are looking actively at acquisitions. We might end up having one series of several clinics, nationally, maybe with some extension to the US. We might end up having three to five clinics on our hands as a series or as singular clinics in different locations.
So you joined the company as its CEO in March this year. What drew you to the company? What do you bring to it?
Let me start with the company. Universal Ibogaine is one of the pioneers in the area of this psychedelic revolution that has been playing out for some time. And, in my view, the definition of the psychedelic revolution, at least one component of it, is the re-harnessing of this great power of psychoactive medicines that we've avoided for decades on the basis of the ramification of the war on drugs. To rehabilitate this power into the area of mental health, addiction being a special important case, and to use their power to be able to do good in that area.
So Universal Ibogaine has chosen Ibogaine, has chosen the field of addiction, and has been going at it now for two and a half years. It's an important and recognized member of the global community. It has great awareness that is built around its platform. It has great advocacy, it is well known, it has taken the first steps in terms of bringing Ibogaine into the medical area and it has connected with Clear Sky in Cancun treating many patients for many years. It is ready, therefore, to be taken to the next level. So as I love brownfield businesses, as opposed to greenfield ones, that is very much applicable to Universal Ibogaine. I do not need to start from scratch.
And going back to me, I wanted to get in. This has been a life mission for me. Mental Health has been around me for many years, through family and friends, and addiction is a special case intertwined. I have spent the past 25 years of my career working on medicines that pertain to the nervous system disorders, with Big Pharma and ultimately with biotech companies.
For me, therefore, this is a personal mission. I want to make a dent when it comes to mental health and addiction in particular, and I think I have found my vehicle for that.
So what should investors expect from Universal Ibogaine in the near to medium term?
investors can expect to see a company that will make them feel very, very good about themselves and their investment. First and foremost, they will see a legacy that they've been part of, this transformation that will finally modulate mental health and make a dent in addiction. They will be very, very proud of this, given that I suspect, like me, many of them will have had addiction and mental health around them.
But they will also benefit from what I believe will be transformative growth in terms of the value of the company in which they are invested. We will give them the upside associated with biotech endeavours through the development of this Ibogaine platform and other psychoactives for addiction. And we will also give them the floor of sustainable, comfortable revenue from day one that comes from our healthcare delivery, managing addiction through innovation at the level of the addiction clinics that we will be acquiring,
I think it's going to be an exciting and comfortable ride for everybody. And I look forward to reporting on that success as we go forward.
Be patient with us. If you have a tool like Ibogaine, and the notion of bringing back psychoactives into their deserted role in treating mental health and addiction, you cannot go wrong. We're going to evolve and you will feel good about yourself and you will be doing very, very well. That sounds all good for mental and investment welfare.
Contact the author at jon.hopkins@proactiveinvestors.com