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Biopharma Co. Makes Major Headway Toward Clinical Trials for Treatment of Stroke

Dave Jackson Dave Jackson, Stockhouse
0 Comments| June 16, 2021

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(CLICK IMAGE TO PLAY VIDEO)

Finding an effective method of preventing the possibility of stroke is something that medical science has grappled with for decades. Now, a Vancouver-based clinical stage biopharmaceutical development company looks to be making significant headway by repurposing a known psychedelic compound that is part of the tryptamine family to help battle stroke.

Algernon Pharmaceuticals Inc. (CSE.AGN, OTCQB:AGNPF, FRANKFURT: AGW, Forum) is a biopharmaceutical company that investigates safe, already approved drugs – including naturally occurring compounds – for new disease applications, moving them efficiently and safely into new human trials. This enables the company to develop new formulations while seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

The company’s business model is highly capital efficient and strives to deliver maximum shareholder value.

In this intriguing video podcast, Stockhouse Media’s Dave Jackson was joined by Algernon Pharmaceuticals’ CEO Christopher J. Moreau to get an inside look at how the company is achieving some amazing breakthroughs via its repurposing science.

TRANSCRIPT BELOW:

SH: Can we first start off with a brief introduction of yourself and overview of the company?

CJM: I'm Christopher J. Moreau. I'm the CEO of Algernon Pharmaceuticals. Algernon is a clinical stage drug development company and as you mentioned in your intro, what's unique about Algernon is that we're not advancing new chemical entities forward into clinical trials, we're looking at compounds that are already approved. Typically they're off patent and they have a relatively strong safety history. We investigate these compounds for new potential uses and then move them into human trials as quickly and efficiently as possible. So we're basically looking for a new blockbuster drug out of an old drug. That's probably the easiest way to think about what Algernon’s business model is.

SH: As briefly mentioned in the intro, Algernon has started a major clinical research program on stroke focused on AP-188. Can you tell us a bit more about the research going into the stroke program using DMT, also known as the “Spirit Molecule?” What is it, how it came about, and how does it work?

CJM: Dimethyltryptamine, DMT is a naturally occurring substance in nature and animals and in plants. It is suspected to be produced by the human brain, but it hasn't been scientifically confirmed. It's been used in ceremonies by certain South American tribes where it's a known psychedelic drug. So when you take DMT you go through a psychedelic experience and it's been well-documented by Dr. Rick Strassman of New Mexico in the eighties, did some significant phase one studies with DMT and what interested Algernon about DMT is that it was shown in studies by a scientist by the name of Olson to help with neurogenesis and neuroplasticity. So it's helping brain cells, neurons to not only grow, but to make new connections and his studies confirmed as well that importantly, a sub psychedelic dose is also effective for neurogenesis and neuroplasticity. Then an additional study done in Hungary showed in a rat model for stroke that when one side of the brain was tied off in this animal study causing a stroke, they were exposed to DMT.

There was a reduction of dead cells called an infarct area. The infarct volume was reduced, and the motor function of the rats were almost fully recovered within 30 days. So this was very telling that DMT, while it's known for its psychedelic effects may very well be an exciting potential therapeutic for people who have suffered a stroke, helping the brain heal, helping it rewire and reducing the deficit that people can suffer after they've had either an ischemic or hemorrhagic stroke.

SH: DMT has been around a long time, so why now for stroke and what has changed?

CJM: DMT is a classified drug that makes it class four. There are different rules and regulations in different monikers in different countries, but it's a highly regulated drug. But of late, there's been a dramatic amount of interest in the investment community for psychedelic drugs, psilocybin, psilocin, DMT as well. There's been predominantly a focus in helping psychiatric or chronic conditions and Algernon took interest in it. This is based on science, it's not only the interest in the market, but in looking at DMT, it was this recent study, I think last year in Hungary that caused us to be quite excited about its potential. We've filed patents for new forms of DMT, this is a difficult area to be in, to get new intellectual property because they're natural occurring compounds, and they've been around and there's been a lot of research. So it's a challenge. If you can establish intellectual property and then look at it from a pure pharma play, moving the drug into phase one phase two trials, can you show efficacy for a particular disease or disease indication, and then how do you move that on for regulatory approval. So there's a resurgence of interest and high water raises all boats. So we're part of that process and we think this is an exciting area to be studying a psychedelic drug like DMT.

SH: Why has a Vancouver-based company chosen the U-K for the Phase 1 study?

CJM: Really in today's global market unless you have a lab attached to your building, you're using contract research in any event. So you're hiring out laboratories or contract research to run your studies so you can work on a global basis. Typically you're going to work in a country that has been accepted for its GLP practices and quality and FDA control. It just so happens that in the UK, Hammersmith Medicines Research who we've contracted to run our phase one study has run a study for DMT for a psychiatric condition, either depression, and in fact having done that, they've gone through the process, they've applied for the license, and they have that background. So it's just easier going with a group that's already done it once and so repeating the process in a very restricted space with a highly controlled substance, it just made sense for us to work with them for our phase one.

SH: In terms of government approval, how does the process work, not just the UK, but the with US FDA and Health Canada?

CJM: It is a complex process, but the first step is really to complete your research. Preclinical, which is a controlled, but it's a little easier to get through the process, the red tape. Then you complete your phase one phase two trial. I mean, we have to keep in mind, there are many controlled substances that are approved for medical use, and so that's not new, but you bring your data forward to the regulatory body, whether it's Health Canada, the US FDA and at some point, if it's efficacious, the drug is working in your phase two study. It's reducing the deficit of patients who have a stroke, it's helping them with rehabilitation. Then at some point there is a process of loosening the rules or the approval for that drug under specific circumstances. Is it distributed strictly by prescription? Is it in a clinical setting? Is it IV? Is that oral tablets? I mean, so how has the drug distributed? How will it be approved? How is it controlled?

But there is a process, there are controlled substances approved, it's data first, preclinical. The preclinical case has been built, then you go into a phase one, phase two, ultimately, a phase three, then you apply for approval and the change in the use of the drug and the classification will come sort of at the end of the road, that's really the process and how it would work.

SH: You also announced a new clinical research program for Ifenprodil and pancreatic cancer. Why is the company expanding research using Ifenprodil when it has many drugs it could investigate?

CJM: So Ifenprodil has been a molecule that we're very excited about. We’re running an IPF and chronic cough trial for Ifenprodil in Australia and New Zealand. It's an NMDA receptor antagonist, and we've found in preclinical studies that it was antitussive. So that means cough. It had an effect on reducing cough, we've investigated it for COVID-19, which is a respiratory disease, but there's additional research that's been done on, on Ifenprodil and specifically, NMDA receptors showing that it may reduce tumor size in certain cancers. So some cancer cells express the NMDA receptor, Ifenprodil binds with that receptor, and there's a bio mechanical process that results. That process can result in the reduction in tumor growth that can reduce the viability of cancer cells. We've made an investment in Ifenprodil.

We've manufactured the API, which is the active pharmaceutical ingredient and it just made sense for us based on some of the strong data we've seen in preclinical studies to sort of pitch our tent on Mount Ifenprodil and just keep investigating it. And it's efficient, because we've already manufactured it, we're going to move it into a finished product stage. And so pancreatic cancer is only one additional indication, it's also been shown to be effective in small cell lung cancer, which was resistant to chemotherapy - so patients that have relapsed. It's also been investigated for PTSD and addictions, or chronic conditions. So it's an exciting molecule, and we thought it was a good business decision to invest in it and investigate it for some other indications.

SH: Can you tell our audience a little bit about the Algernon management team and how you are making waves by doing things differently in the drug development space?

CJM: We run a very lean team. In terms of full-time staff we basically have two scientists, Dr. Chris Bryan, we have just brought on a research associate who is helping Dr. Bryan and our research team, and I'm, full-time. We really do use contract research for the majority of all of our other work. And I think in terms of making waves, our view is that once we've identified data in a preclinical well-run animal study, our view is to move that drug as quickly as we can into a human trial. You know the body of the bio mechanisms involved in humans compared to animals are very different. So you can run 50 animal trials and show some pretty exciting data, but what happens when you get the drug into man, that's what's really key, and so one exciting element of drug repurposing is that if you have a known safety history, you can often move a compound very quickly into a human trial. Even if it's a pilot study, you can do that cost-effectively. Find out if the drug is working in man, have a moment of inflection corporately, and then you have a little more time to do more fulsome studies, additional phase one, or phase two studies, and even going on to phase three. So it's that the capacity to run trials quickly but properly, and to do it with capital efficiency and get answers. I mean that's what I think is the big difference with Algernon compared to some other companies in this space.

SH: It’s been a busy year for Algernon, and investors are taking notice, yet you’ve had a bit of a roller coaster ride on the markets. What can you tell our investor audience regarding the current valuation of your stock and why you think it’s a good buy right now?

CJM: You know, I've said many times over the last couple of months that Algernon is not a COVID company, but if you sort of look at the stock and the trading, I think the COVID story did consume much of the oxygen in the room and has for the last period of time. We'll wait to see what comes of the hard work we put in and the research we did in Ifenprodil, but Algernon was always more than our investigation of Ifenprodil for COVID, IPF and cough. Now we're working on DMT for stroke, we've added pancreatic cancer. So we have a number of irons in the fire and based on our model, we're looking for the next blockbuster drug for a repurposed solution. It's best that we have a number of irons in the fire, the more drugs that we investigate, the more drugs we move into phase two trials, the better chances that we'll end up finding a drug that does work and then people will be able to have a new treatment. That's the exceptional part and from a corporate or investment perspective, I think you'll see some tremendous value creation if we're successful. So multiple compounds, multiple indications, that's our model and that's the model we're fulfilling.

SH: Moving into the rest of the year, what milestones should investors be keeping an eye out for?

CJM: I think milestone one is feedback from the FDA on our COVID story. Let's see what next steps. Milestone number two is the phase one DMT stroke study and that we're hoping to start in Q3 to Q4 of this year. We should have IPF and chronic cough data by the end of this year, and based on the feedback from the FDA, we will be filing a pre-IND for pancreatic cancer. We may be starting a Phase One study for that indication sooner than the Q1 of 2022. So we've got a number of milestones for investors to think about and watch as the as the news unfolds here.

SH: Thanks for the insights into Algernon, Chris! Be well and stay safe.

CJM: Thanks, Dave. Good to speaking to you, take care.


For more information, visit https://algernonpharmaceuticals.com/.

FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.



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