Algernon Pharmaceuticals has received approval to conduct a Phase 1 clinical study of an intravenous formulation (IVF) of DMT for the treatment of stroke in the Netherlands.
Algernon Pharmaceuticals’ decision to investigate DMT and move it into human trials for ischemic stroke was based on multiple independent, positive preclinical studies. Results from the studies demonstrated that DMT helps mitigate tissue damage and 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.
Addtionally, Algernon carried out its own murine cortical neuron outgrowth preclinical study which demonstrated that DMT, in sub-psychedelic doses, increased the growth of cortical neurons by up to 40 per cent compared to control.
Author of the best-selling book DMT: The Spirit Molecule, as well as Algernon consultant, psychiatrist and psychopharmacologist, Rick Strassman MD, commented: “I was drawn to DMT’s endogenous nature and possible role in naturally occurring altered states of consciousness such as dreams and psychosis, as well as being a prototype for other psychedelic drugs in common use.”
Strassman’s NIH-funded Phase 1 study of DMT, which ran from 1990-1995 at the University of New Mexico, was the first new American clinical research with psychedelic drugs in a generation.
The study assessed biological and psychological effects in normal volunteers and demonstrated that studies of psychedelics could be done safely in humans.
Strassman continued: “Our careful assessment of psychedelic and non-psychedelic doses of DMT established guidelines for studies utilising its neuroplastogenic effects in stroke, an application I would not have predicted at the time.
“These more recent findings of DMT’s effects have opened an extraordinarily promising set of potential therapeutic applications for Algernon to explore.”
CEO of Algernon Pharmaceuticals, Christopher Moreau, commented: “We look forward to getting our DMT clinical stroke program started with our Phase 1 study at CHDR in the Netherlands.
“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.”
The company received approval for the study from the Stichting Beoordeling Ethiek Biomedisch Onderzoek (“BEBO”), an independent Medical Research Ethics Committee (MREC). The trial will be conducted at the Centre for Human Drug Research (CHDR) in Leiden. Screening for the study will begin shortly and dosing of the first subject is expected in Q4, 2022.
Since there have already been several Phase 1 studies successfully conducted on DMT, Algernon is not anticipating any serious adverse events or safety issues arising from its study. The reason that the company is planning to conduct a Phase 1 study and not directly advance DMT into a Phase 2 study is that it is investigating prolonged intravenous infusion of DMT, for durations which have never been clinically studied.
The resulting data generated will help the company to plan both its Phase 2 acute stroke and rehabilitation studies more effectively.
Dr David Nutt, Professor of Neuropsychopharmacology at Imperial College London, also an Algernon consultant, added: “I am pleased to see Algernon moving forward with the CHDR, with whom I have worked in the past and respect greatly.
“Although the study is in healthy volunteers, the protocol includes study of some markers which may give some early clues about potential benefits in stroke victims.”
