VANCOUVER – Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) a clinical stage pharmaceutical development company reported that it has established a clinical research program for the treatment of stroke focused on AP-188, a known psychedelic compound that is part of the tryptamine family (other drugs in the tryptamine family include psilocybin and psilocin). Algernon plans to be the first company globally to pursue DMT for stroke in humans and is planning to begin a clinical trial as soon as possible in 2021.
Algernon has also filed new provisional patents for new forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke. The company has also filed claims for combination therapy of DMT and Constraint Induced Movement Therapy .
The company announced in early January that it would be establishing a new clinical research program in Q1 2021 to add to its current pipeline. Repurposing DMT from its psychedelic effects to a new potential treatment for stroke could have a positive impact on the millions of people that suffer the debilitating consequences of a stroke each year.
The decision to investigate DMT and move it into human trials for stroke is based on multiple independent, positive preclinical studies demonstrating that DMT helps promote neurogenesis as well as structural and functional neural plasticity. These are key factors involved in the brain’s ability to form and reorganize synaptic connections, which are needed for healing following a brain injury.
A recently published preclinical study in an animal model for stroke, showed that rats treated with DMT recovered motor function more quickly and to a greater extent, and also exhibited lower lesion volumes when compared to control group animals that did not receive DMT. Key data from the study achieved statistical significance.
Unlike other companies recently researching psychedelic drugs, Algernon will be focusing on a sub-hallucinogenic, or microdose of DMT provided by continuous intravenous administration. By pursuing a continuous active microdose, the goal will be to provide patients with the therapeutic benefits of DMT, without having a psychedelic experience. This is an important element when considering treating a patient who has just suffered a stroke, wherein medications that cause a hallucinogenic response would cause unwanted confusion and stress.
The company also believes that a microdosing approach to developing a DMT treatment may enable a much wider review and acceptance of its data, including garnering the early interest of research investigators, the interest of clinical trial patients, and ultimately clinical acceptance. Algernon’s approach may also allow for a quicker pathway to regulatory approval including a Breakthrough Therapy designation from the U.S. FDA, which enables priority review of a drug candidate if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.
“While other research is exploring DMT for its hallucinogenic qualities and effects, Algernon will be working to unlock DMT’s non-psychedelic potential to help promote healing and recovery in the brain from a stroke, one of the most devastating injuries a human being can experience,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “The Algernon team, which now includes global experts in DMT and stroke research, is uniquely positioned to quickly repurpose DMT into human trials in the most cost and time effective way possible, just as we did with Ifenprodil in the on-going Phase 2 trial for Idiopathic Pulmonary Fibrosis (“IPF”) and chronic cough, as well as with our on-going COVID-19 trial.”
N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazonian basin. DMT can also be synthesised in a laboratory.
At higher doses, DMT has a rapid onset, intense psychedelic effects, and a relatively short duration of action with an estimated half-life of less than fifteen minutes. Like other hallucinogens in the tryptamine family, DMT binds to serotonin receptors to produce euphoria and psychedelic effects. Because the effects of DMT do not last very long, it has been referred to in some circles as the “businessman’s trip”.
Named the “Spirit Molecule” by Dr. Rick Strassman, an American clinical associate professor of psychiatry and DMT research pioneer, DMT has been shown to induce neuroplasticity in a number of key preclinical studies. DMT is believed to activate pathways involved with forming neuron connections and has been shown in studies to increase the number of dendritic spines on cortical neurons. Dendritic spines form synapses (connections) with other neurons and are a major site of molecular activity in the brain.
While Dr. Strassman’s Phase 1 bolus intravenous human study identified the sub-hallucinogenic dose of DMT in humans, another preclinical animal study demonstrated this same dose level still retains the neuroplastic effect seen in higher hallucinogenic doses.
Algernon will be investigating an intravenous sub-hallucinogenic dose of DMT in its research and clinical studies.
Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and 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.
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