Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) is a drug repurposing company about to launch a Phase 1 clinical trial in humans evaluating the psychedelic N,N-dimethyltryptamine (DMT), or AP-188, as a treatment for people who have suffered a stroke. The study will be conducted in the United Kingdom and as such, Algernon is awaiting a green light from regulators.
Host Cyndi Edwards noted that preclinical studies have shown DMT appears to cause brain cells to grow in such a way that they may make new connections, an activity called neuroplasticity.
Dr. David Nutt, a consultant to Algernon, explained that in the last few years, drugs like DMT have been discovered to stimulate the serotonin 2a receptor in the brain and to increase production of synapses that link to neurons. Synapses allow neurons, or building blocks of the brain, to communicate. The more synapses one has, the better their brain functions.
By facilitating brain connectivity, DMT may help heal the brain post stroke, Nutt said. Oftentimes, people who suffer a stroke no longer can carry out certain functions and need to relearn those. Some of that activity happens in parts of the brain that may recover from a stroke.
Two preclinical key studies support the hypothesis that DMT may aid in neuroplasticity. One, in which DMT was given to rats after a stroke, showed improvement during recovery. The second, conducted at a university in Hungary, showed DMT reduced some of what caused the brain damage during the stroke.
"Should we be hopeful that DMT may help stroke patients in both ways?" Edwards asked Nutt.
"Absolutely," he answered, and cited that as his reason for agreeing to work with Algernon. "The fact that it may work on both the processes of reducing the harm of the stroke and also facilitating recovery from the stroke, that makes it very different from all the approaches we've had before, which have largely focused on reducing the size of the stroke damage rather than facilitating recovery."
Dr. Rick Strassman discussed his work in the 1990s researching DMT, what he coined "the spirit molecule." Whereas some of his research was on whether or not DMT elicited a mystical experience, he had multiple goals, he said. He wanted to show that a clinical study of a psychedelic drug classified as Schedule I could be done in humans, show that psychedelics could be given to people safely and that solid data could be generated from studying psychedelics in humans. Strassman achieved all three.
"I thought that the normative data that we had generated in the DMT work would open the door for any number of possible studies in the future. Mostly I was thinking about psychotherapeutic studies," he said. "With the recent data pointing at neurogenesis and neuroplasticity, that's opening up a whole other area of potential therapeutic work."
Strassman said Algernon should not have any trouble in terms of significant adverse effects from DMT in its upcoming Phase 1 trial because subpsychedelic doses, shown to be safe, will be used. The intent of the study is not to induce a psychedelic experience.
Algernon CEO Christopher Moreau said that Algernon committed its research dollars to investigating DMT as a possible stroke treatment for two key reasons. One is the compelling positive preclinical data. The other is the paucity of treatments for most stroke patients.
"I think that we have a shot, a very reasonable shot based on the clinical data, that DMT can actually help stroke patients," Moreau said.
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