Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE), a Canadian publicly traded drug development company that recently applied to up-list on the Nasdaq, announced that it plans to be the world’s first company to test the psychedelic drug DMT in stroke patients, and it's close to achieving its goal.
With a Phase 1 DMT clinical study planned to start before the end of March 2022 to test a new IV formulation of N,N-dimethyltryptamine (DMT), and a Phase 2 acute stroke study planned to begin before the end of the year, the company said it is far ahead of others thinking about psychedelic drug stroke research.
“It is clear from the early preclinical data that DMT encourages neurons to grow and make new connections called neuroplasticity,” said Algernon Chief Executive Officer Christopher Moreau. “The strong preclinical data has motivated me to see if DMT will help treat people that have suffered a stroke.”
"Biotech is always risky, but Algernon has found ways to make the process faster and remove a significant part of the overall risk. Combine this with multiple other drug candidates in their pipeline, total addressable markets in the billions, and you have the potential for a winner of staggering proportions."
—PennyQueen, independent investor
Dr. Rick Strassman, who conducted early research on DMT in the 1990s and wrote a book called “DMT: The Spirit Molecule,” said he has yet to see preclinical data on any other drug that appears more promising as a possible treatment for stroke patients than DMT.
“When I did my research on DMT, I was focused on its psychoactive properties,” he said. “But it is clearly showing in the preclinical research that it appears to also have structural and functional roles in helping the brain heal from ischemic injury.”
Strassman, along with other global experts on psychedelic drugs, stroke care physicians, and stroke research specialists have signed on to help Algernon as consultants to guide the company as it moves into human trials. Strassman, Moreau, and consultant Dr. David Nutt appeared on Streetwise Live! on Jan. 27, 2022 to discuss the promise of DMT.
Here’s why this is important
Each year, there are approximately 15 million strokes globally, with nearly 800,000 occurring in the U.S. alone, according to the Centers for Disease Control and Prevention. Approximately 87% of all strokes are ischemic strokes, which occur when a blood clot blocks blood flow to the brain causing brain neurons to die.
Currently, medication treatment for an ischemic stroke is limited to a clot buster called a Tissue Plasminogen Activator (“TPA”), or simple blood thinners. Patients being treated with a TPA must receive the drug within three to 4.5 hours of the stroke injury (the treatment window). For this reason, only about 2% to 10% of stroke patients receive TPA on a global average, according to a journal article published by the American Heart Association.
But for most stroke patients, the current standard of care is having your vitals stabilized (blood pressure, oxygenation, blood glucose, heart rate, and hydration) and to hope and pray for the best. “One can truly say that despite all our medical advances, in the year 2022, there is very little for the vast majority of stroke patients accept hope and prayer and to me that’s not good enough, we need effective treatments as well,” Moreau said.
Enter DMT, a known psychedelic compound. DMT occurs naturally in many plant species and animals — including humans — and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazonian basin in a drink called ayahuasca.
Several preclinical stroke studies have demonstrated that DMT helps reduce brain tissue damage and promote neurogenesis (growth of new neurons) as well as structural and functional neural recovery (plasticity), the company said. These are key processes involved in the brain’s ability to form neurons and reorganize synaptic connections, which are needed for healing following a brain injury.
With many hundreds of stroke treatment agents having failed in drug development pathways over the past 40 years, Moreau said DMT, the spirit molecule, may be just what the doctor ordered to help save your life.
"The company has a lot of good things in the works, and there should be a constant flow of news. It's the kind of company that could be a $500 million market cap in a takeout after success in any one of several drug trials."
—Bob Moriarty, founder of 321gold.com
Independent investor PennyQueen said Algernon's practice of repurposing drugs that have already been approved for one indication to use with another condition is a reason it's one of only two pharmaceutical stocks in her portfolio.
"Biotech is always risky, but Algernon has found ways to make the process faster and remove a significant part of the overall risk," she wrote. "Combine this with multiple other drug candidates in their pipeline, total addressable markets in the billions, and you have the potential for a winner of staggering proportions."
Algernon can generally skip the first phase of trials for a repurposed drug because of its established safety history, said Steven Palmer, chief information officer and president of AlphaNorth Asset Management, one of Canada's top-rated hedge funds.
"They already know that the drug is safe, and they can get right into the Phase 2, to identify whether it works or not," Palmer said.
Bob Moriarty, founder of 321gold.com, said in January that he believes the company has a lot of "potential."
"The company has a lot of good things in the works, and there should be a constant flow of news," Moriarty said. "It's the kind of company that could be a $500 million market cap in a takeout after success in any one of several drug trials."
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