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Algernon hires Charles River for DMT study

2021-02-08 10:21 ET - News Release

Mr. Christopher Moreau reports


Algernon Pharmaceuticals Inc. has signed an agreement with Charles River Laboratories Inc. for preclinical studies of AP-188 (N,N-Dimethyltryptamine or DMT) for the company's stroke clinical research program. Algernon's preclinical study of DMT will be conducted at the Charles River research facility in Finland.

Charles River Laboratories is an American corporation specializing in a variety of preclinical and clinical laboratory services for the pharmaceutical, medical device and biotechnology industries. It also supplies assorted biomedical products and research and development outsourcing services for use in the pharmaceutical industry.

Algernon recently established a clinical research program for the treatment of stroke focused on DMT, a known psychedelic compound that is part of the tryptamine family. The company 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.

The company's decision to investigate DMT, called the spirit molecule, 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.

Unlike other companies recently researching psychedelic drugs, Algernon will be focusing on a subhallucinogenic, 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 is very pleased to have retained Charles River Labs, a trusted vendor that we have worked with before on other research projects," said Christopher J. Moreau, chief executive officer of Algernon Pharmaceuticals. "They have all of the necessary permits and licences to handle DMT, which will allow us to move quickly with our research program. They are a recognized world leader for preclinical neurological studies."

DMT background

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 synthesized 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 15 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, and Algernon consultant, 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 subhallucinogenic 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 subhallucinogenic dose of DMT in its research and clinical studies.

DMT -- building the case for stroke

Data from a study published in Experimental Neurology in May, 2020, showed that, in a rat model of cerebral ischemia-reperfusion injury, DMT reduced the infarct (dead cells) volume and improved functional recovery.

Key findings:

  • Animals treated with DMT displayed lower lesion volumes than control animals measured by MRI (magnetic resonance imaging) 24 hours following the occlusion (p equals 0.0373).
  • Animals in the DMT group improved motor function more quickly and to a greater extent than the control group; the differences became significant on the fourth day (p equals 0.0325) and persisted throughout a 30-day follow-up.
  • mRNA expression of brain-derived neurotrophic factor (BDNF) was upregulated in both the peri-infarct cortex (p equals 0.0273) and contralateral cortex (p equals 0.0048) as well as in serum (p less than 0.0001). BDNF is a key facilitator of neuroplasticity.

About Algernon Pharmaceuticals Inc.

Algernon is a drug repurposing 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 United States or Europe to avoid off-label prescription writing.

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