Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) said it has received approval from the independent Medical Research Ethics Committee of the Netherlands, the Stichting Beoordeling Ethiek Biomedisch Onderzoek, to conduct a Phase 1 clinical study of an intravenous formulation of the psychedelic tryptamine N,N-dimethyl tryptamine (DMT) for the treatment of stroke in the country.
The trial will be conducted at the Centre for Human Drug Research (CHDR) in Leiden, the company said.
Algernon said its decision to investigate DMT and move it into human trials for ischemic stroke was based on multiple independent, positive preclinical studies demonstrating that DMT helps mitigate tissue damage and promote neurogenesis as well as structural and functional neural plasticity.
This body of research includes the company’s own murine cortical neuron outgrowth preclinical study which showed that DMT, in sub-psychedelic doses, increased the growth of cortical neurons by up to 40% compared to control.
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The purpose of this upcoming study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by a prolonged infusion, for durations which have never been studied clinically, according to Algernon.
The first part of the study will use a single-escalating dose design aimed at identifying a safe and tolerable dose that will not produce psychedelic effects, while the second part will test the effects of repeated administrations of this dose.
Algernon plans to begin screening shortly and dose the first subject in the study in 4Q 2022, with up to 60 healthy volunteers expected to enroll across the two parts of the study.
The company said it does not expect any serious adverse events or safety issues to arise from the Phase 1 study, which it said would generate data to help Algernon plan both its Phase 2 acute stroke and rehabilitation studies more effectively.
"Although the study is in healthy volunteers, the protocol includes the study of some markers which may give some early clues about potential benefits in stroke victims,” noted Dr David Nutt, Professor of Neuropsychopharmacology at Imperial College London and Algernon consultant.
Algernon CEO Christopher Moreau added: "This study will provide important information on dosage and duration of our new DMT IVF formula to help us better plan for our Phase 2 where we plan to test the drug with both acute and recovering stroke patients."
Founded in 1986, CHDR is an independent institute that specializes in cutting-edge early-phase clinical research.
Algernon is a drug-repurposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications.
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