Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) said it has entered into an investigator-initiated clinical trial agreement (CTA) with Yale University for the investigation of multiple intravenous doses of N,N-Dimethyltryptamine (DMT) for the treatment of depression.
The trial's principal investigator is Dr. Deepak Cyril D'Souza, professor of psychiatry and director of the Schizophrenia Neuropharmacology Research Group at the Yale University School of Medicine, an experienced researcher with DMT and other controlled substances.
"The study may enhance our current understanding of the dosing regimen in the subjective effects induced by DMT," said D'Souza in a statement.
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As part of the CTA, Algernon will provide current good manufacturing practice (cGMP) DMT for the study. In return, Algernon will jointly own intellectual property (IP) around the clinical use of DMT arising from the study developed jointly by Algernon and Yale, and the option to negotiate licenses to both IP developed jointly and IP developed solely by Yale - subject to rights reserved by the US government in conjunction with publicly funded research.
In addition, the company will receive data from the study, which may assist in its DMT stroke research program.
"After careful consideration, we chose to support Dr. D'Souza's clinical DMT study and work with Yale University," said Christopher J Moreau, CEO of Algernon Pharmaceuticals.
"Although the treatment of psychiatric disorders with DMT are not the company's current focus, we have patents pending on novel forms of DMT which could potentially be used across a broad range of diseases. In addition, we believe the data generated from this study may help inform Algernon's stroke research program."
DMT is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, and psilocybin. 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 Amazon. DMT can also be synthesised in a laboratory.
The proposed double-blind, placebo-controlled, crossover-controlled study will compare different bolus and constant infusion dosing regimens of DMT in healthy control participants and individuals with depression.
"A rising tide lifts all boats, and we feel a corporate responsibility as well to improve global awareness and support psychedelic medicine research when possible. It is in that spirit that we also chose to become the lead sponsor of Wonderland, the world's largest conference on psychedelic medicine to be held November 3-5 in Miami," Moreau said.
Yale School of Medicine is one of the world's leading centers for biomedical research, advanced clinical care, and medical education.
Algernon is a Canadian clinical stage drug development company investigating multiple drugs with global unmet medical needs. Algernon has active research programs for idiopathic pulmonary fibrosis (IPF) with chronic cough, chronic kidney disease, and a psychedelic program investigating a proprietary form of DMT for stroke.
Contact the author at jon.hopkins@proactiveinvestors.com