Algernon Pharmaceuticals has announced that its subsidiary, Algernon NeuroScience (AGN Neuro), has dosed the first subject in its Phase 1 clinical study of an intravenous formulation of DMT (AP-188) in the Netherlands.
The Phase 1 study is aiming to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion, for durations that have never been studied clinically.
Several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, will also be recorded.
Author of DMT: The Spirit Molecule and Algernon consultant, Dr Rick Strassman, commented: “I am delighted that Algernon NeuroScience has begun their Phase 1 DMT study.
“Based on what we know about DMT, I believe a prolonged infusion of a sub-psychedelic dose of this compound will be safe and may activate multiple neuroregenerative pathways, including elevations of BDNF. Such effects may prove beneficial in ischemic stroke patients acutely and in their rehabilitation.”
Algernon consultant Dr David Nutt, who is the Edmund J. Safra Professor of Neuropsychopharmacology in the Division of Brain Science, Department of Medicine, Hammersmith Hospital, Imperial College London, stated: “A significant number of promising stroke drugs have failed because they were focussed on trying to be neuroprotective of the brain during a stroke.
“It appears from the pre-clinical data that DMT is promoting neuroplasticity, a key mechanism in recovery once the stroke has occurred, which is a new and exciting approach to stroke treatment.”
The resulting data generated from the study will help the company to plan both a Phase 2 acute stroke and rehabilitation study more effectively.
The company states that it has been working with its DMT and stroke experts from its medical advisory board to help design the planned Phase 2 studies in acute stroke and rehabilitation. The planned studies are expected to dose patients immediately following confirmation of their ischemic stroke diagnosis by imaging and will test the effects of DMT versus placebo on both the progress of the infarct and also on patients’ recovery following the stroke.
“This Phase 1 study is an important milestone as we advance our investigation of DMT for the treatment of stroke,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals.
“We anticipate receiving data from this study in Q3 2023, and potentially beginning Phase 2 studies in stroke patients by the end of the calendar year.”
