Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA) patent applications for DMT, a psychedelic compound to treat strokes include the addition of two novel salts creating two entirely new drug compounds, the company has announced.
The pure or freebase form of N, N-dimethyltryptamine (DMT) occurs in nature so it can’t be patented, but the addition of nicotinate and pamoate salts slightly alters the drug’s chemical fingerprint, making new and separate structures in the eyes of the patent office.
“If we just took pure DMT and started to do clinical studies and spend money on it, when we get it approved, can anyone make DMT? Sure,” Algernon Chief Executive Officer Christopher J. Moreau said. “So, by adding various salts to DMT, we’re actually making new versions of DMT that we can call our own. Also, the salts on their own have shown positive effects in the brain and so we are really strengthening our position on both the intellectual property front and also in their potential as a stroke treatment.”
The application of DMT to help stroke patients has some, like independent investor PennyQueen, "beyond excited."
"Research into hallucinogens has become popular lately,” she wrote for Streetwise Reports. “The potential is too good to ignore.”
New Version of Drug ‘Actually Better’
Over 15 million people suffer strokes every year, killing millions and leaving millions more permanently disabled. Strokes cost more than $45 billion annually in the United States, according to health officials.
The nicotinate and pamoate salts were included when Algernon filed the patent applications for DMT in early 2021, according to the Vancouver-based company, which repurposes drugs approved for one indication to use for other conditions.
The salts are not inert and may assist with the efficacy of DMT, the company noted. Both nicotinate and pamoate have been found to improve functioning after stroke in studies.
“We hope that the new versions we’re making (of DMT) are actually even better than what is currently available,” Moreau said.
While DMT has never been approved as a drug, it has been in use for centuries in religious ceremonies as a traditional spiritual medicine and has already been involved in some Phase 1 studies.
Algernon plans to be the first company in the world to investigate DMT as a potential treatment for ischemic stroke patients. Several preclinical stroke studies have demonstrated that the drug helps reduce brain tissue damage and promote the growth of new neurons and structural and functional neural recovery following a brain injury, the company said.
“Rats from an animal stroke study that were given DMT had a smaller area of damaged brain cells and showed an almost full recovery of motor function after 30 days when compared to the control group," Moreau said.
Algernon also announced that the Phase 1 study of the drug will begin in Europe in September and that it has contracted with the Centre for Human Drug Research and its affiliated pharmacy at the Leiden University Medical Center in the Netherlands to complete the intravenous formulation (IVF) of the drug that will be used in the study.
Up to 60 healthy volunteers will be enrolled across the two parts of the study, which will include “psychedelic experienced and psychedelic naïve patients,” according to the company.
Hallucinations Not Needed
But while much of the current research on DMT targets treatments for PTSD, depression, and addiction using the hallucinogenic qualities of the molecule, Algernon is taking a different approach.
"Algernon will be investigating DMT at sub-psychedelic doses, meaning we are not creating the psychoactive experience in patients," Moreau said. "The preclinical data has shown that a microdose of DMT still causes the growth in the neurons, which means patients who have suffered a stroke could be given a small enough dose of DMT to not cause hallucinations. The preclinical data suggest that with DMT, a person may not need the hallucinogenic experience for the drug to potentially help the brain repair itself."
Algernon has retained globally recognized leaders in psychedelic drug research as consultants, including Dr. David Nutt from the Imperial College of London's Centre for Psychedelic Research, and Dr. Rick Strassman, author of the book "DMT: The Spirit Molecule."
The company has also brought in two leading clinical stroke experts from the UK to help guide its human studies.
The company said its drug repurposing strategy saves time, capital, and accelerates the traditional timeline for advancing a new drug to market. Moreau said it can save years of early research and development work, and millions in research and development costs.
"The benefit of this strategy is that it shortens the timeframe of the trials because they can generally skip the Phase 1 because they already know that the drug is safe, and they can get right into Phase 2 to identify whether it works or not," AlphaNorth Asset Management cofounder Steve Palmer told Streetwise Reports.
Algernon announced on July 4 that it closed a CA$1.16 million public offering of 309,117 units at CA$3.75 per unit. The money will be used for research and development, general and administrative expenses, and working capital.
The company has a market cap of CA$5.78 million with 1.67 million shares outstanding. It trades in a 52-week range of CA$13 and CA$3.25.
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