The Canadian company Algernon (CSE:AGN; Frankfurt:AGW0; OTCQB:AGNPF) is the headline sponsor for the Wonderland psychedelic medicine conference held in Miami from November 3 to 5. Algernon CEO Chris Moreau expects the decision to prominently back the event will raise the company’s profile. “We view Algernon as a Janis Joplin voice singing to a junior high crowd right now,” Moreau said. “We’re sort of undiscovered, but the parents in the audience think the music is fantastic. People are looking at each other in amazement, but it’s in the school gym.”
The Vancouver–based company has three drugs in its pipeline — ifenprodil and repirinast for inflammatory disorders and the psychedelic compound DMT for ischemic stroke rehabilitation.
In late October, the company announced a research alliance with Yale University to explore using DMT in a Phase 2 depression study.
In a recent interview, Moreau shared details on its DMT focus, including its Yale partnership and its presence at Wonderland.
How did Algernon enter into a DMT research partnership with Yale?
Moreau: All of the psychedelic drugs that most people are familiar with — psilocybin, psilocin and DMT — are highly regulated. Even research scientists trying to get access to those compounds for drug development can struggle to access them. You have research-grade and clinical-grade cGMP material. Even getting access to research-grade materials that you would use in animals is difficult.
We found this out last year. When we launched our program, we reached out to a couple of our global contacts. One was in China. Another was in Canada, and there were a couple in the U.S. The Chinese company came back and said, ‘We can’t even use the name DMT in our communication. It’s completely forbidden.’ There was a university in the U.S., but it was not synthesizing enough quantity, and it was not cGMP. There were some companies in the U.S. and Europe, but they were already committed to other projects. Then, we got lucky. There was a manufacturer in Canada called Dalton Pharma. We entered into a contract with them in 2021. They had all the licenses to produce psychedelic compounds and had done a run of DMT for another company. We stepped up and said, ‘We want a quantity that would allow us to get through our Phase 1 study.’ And we signed a contract and away they went. It’s months and months of the development process. Under cGMP, they have to validate the process and produce an engineering run. And then they go into manufacturing.
Due to COVID, even trying to get into manufacturers’ cGMP suite means you’re booking a year in advance. So right now, for us to make our second quantity for our Phase 2 study, we’re putting the order in now, but they won’t be able to manufacture it until next spring. So we were fortunate, and we had a few calls over the last few months and some emails from companies asking if we would consider if they could partner with us or get access to our DMT. My CSO contacted me a few months ago and said that Yale had reached out. An investigator wanted to do a Phase 2 trial for depression. He tried to do ascending doses and for longer durations but differential doses. One of his objectives was to see if slowly infusing and increasing the dose with the patient will reduce this psychedelic shock event. If you do a bolus injection of DMT very quickly, the patient can experience profound psychedelic hallucinations, which can be overwhelming for some people.
So the Yale research is looking to do a more gradual infusion to relieve depression?
Moreau: Yes. Yale Professor Deepak Cyril D’Souza is an experienced researcher with DMT and other controlled substances. He wanted to learn more about extended doses with a longer duration while changing the dose concentration.
So we entered into a conversation with Yale to discuss how we could benefit from a research partnership. We began to discuss what ended up being a clinical trial agreement, where Algernon provided the DMT required for their study. In exchange, we have access to the data. We have certain intellectual property rights around data that comes from the study.
Most of the research on psychedelics involves a single dose. With DMT, you’re giving them a single bolus psychedelic dose of DMT, which is greater than 0.2 mg per kg. But we, on the other hand, have discovered, in the literature and with our own in vivo study, that sub-psychedelic doses are also biologically active and help the brain with neuroplasticity.
DMT encourages the creation of brain-derived neurotrophic factors (BDNF). BDNF’s role has also been investigated in neuroplasticity. For example, BDNF goes down after a stroke, and it doesn’t recover. However, you can increase BDNF through exercise and, in this case, through an infusion of DMT.
We suggest that you deliver a sub-psychedelic dose that’s still neuronally active that gets in the brain and causes an increase in serum BDNF. Plasma BDNF is tied to neuroplasticity. So it’s a critical protein for the neurons to not only survive but also for neural networking.
In our Phase 1 DMT study, patients get an infusion for multiple hours that brings them close to a psychedelic dose but not quite.
There could be some informative data from the Yale study. We are supporters of DMT research because we believe that research and science trumps fear. The fear of psychedelic drugs is not rational or logical. These drugs need to be investigated with an open mind safely by research scientists so that we can understand if they can help people with either disorders or diseases, including depression or PTSD. In our case, we’re looking at stroke. But that could extend to other brain injuries. When damage occurs to the brain, whether it’s a chronic or an acute event, we want to better understand the natural healing mechanism and how DMT could help support that. We know that most of the recovery of a patient’s deficit, whether it is cognitive motor function or speech — will occur in about four and a half weeks. And then the recovery sort of peters out at the six months where you don’t see any changes or improvement. We may find out that long-term infusion of DMT during the post-stroke and during the recovery period may be the most efficacious. We don’t know yet. And we’re starting down the path.
Can you say more about Algernon’s decision to focus on developing DMT?
Moreau: This is a tough space to be in. We wanted to look at it as a pure pharma play. We’re not going to build clinics and hire therapists. So our approach is to see if there is a pharma play.
We learned that Nardai had published his rat inclusion study showing that DMT reduced infarct volume and motor function. That was no longer novel. We did file for constraint-induced movement therapy (CIMT), which is when you have a stroke, clinicians will restrict your good arm or limb and force you to use the other during the rehab. And that’s been shown to have some impact. So we’ve filed for the use of DMT as a rehab therapeutic.
But our key IP focuses on the fact that we’re going to rely on not DMT fumarate, which is how the core molecule is usually paired. Our DMT is paired with either nicotinate or pamoate. And these are two different salts that are neuronally reactive. Pamoate has been shown to improve neuroplasticity — never mind paired with freebase DMT. So we have all of the components of the proprietary molecule composition of matter patent, which we’ve filed. The U.S. Patent Office told us that, in their view, it was novel after performing their initial searches. And that would mean that we could use our proprietary DMT molecule to treat various conditions, including depression. Depression is not our core focus, but we could offer DMT for several indications. That was also part of the spirit of why we partnered with Yale.
Please share more about what you hope to convey at the psychedelic medicine event Wonderland.
Moreau: We’ve got this world-class research program. We don’t just have DMT. We have a number of compounds that we are advancing.
We thought the sponsorship of Wonderland could help get the Algernon story out.
On November 4, I’m delivering a keynote on effectively repurposing DMT. To be clear, it’s not a true repurpose. Repurpose is taking a drug already approved off patent and finding a new indication. In this case, DMT has never been approved, but it is safe. And in fact, it has primarily been used historically for its psychedelic purposes. But I’m going to discuss and explain how to leverage preclinical data and move a drug more quickly than a new chemical entity (NCE), where you’re starting in the lab. You know, 90% of drugs fail in preclinical. I’ll be talking about our model and, of course, a bit about stroke.
Most people don’t understand how an ischemic stroke can affect people and what the deficits are. I’ll explain how DMT could help.
On November 5, I’ll deliver a science session where I’ll walk through several clinical studies that help argue that the investigation of DMT for stroke is not only worthwhile, it’s exceptionally exciting. It’s a new approach. When you have a hypoxic event, you’ve got this low blood oxygen, and all the damage is a huge cascade of damage that occurs. DMT is more about how we help the brain do what it has to do to try to heal in that damaged area that never will come back. But the brain is trying to bridge around it and make new connections so you can restore whatever function that may have been affected. And that’s the crux of it. It’s very exciting. It’s never been done before.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs