Canadian clinical-stage psychedelics company Algernon Pharmaceuticals (OTCQB:AGNPF)'s newly created subsidiary Algernon NeuroScience (AGN Neuro) has dosed the first subject in its Phase 1 clinical study of proprietary IV formulation of DMT, AP-188.
The trial is being conducted at the Centre for Human Drug Research in Leiden, the Netherlands.
Renowned psychopharmacologist and Algernon consultant Prof. David Nutt commented that, while "a significant number of promising stroke drugs have failed because they were focused on trying to be neuroprotective of the brain during a stroke," preclinical data shows 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 purpose of this Phase 1 study is to identify the safety, tolerability and pharmacokinetics (PK) of IV-administered DMT, followed by prolonged infusion for durations not yet clinically studied.
As 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 the study and expects the data generated will help plan both Phase 2 acute stroke and rehabilitation studies more effectively.
"This Phase 1 study is an important milestone as we advance our investigation of DMT for the treatment of stroke," CEO Christopher J. Moreau said. "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."
More On How DMT Works
DMT is a psychedelic that belongs to the tryptamine substances family. It is an agonist of multiple receptors including serotonin and the sigma-1 receptor.
The latter is a multi-faceted stress-responsive receptor that promotes cell survival, neuroprotection, neuroplasticity and neuroimmunomodulation.
DMT promotes the release of Brain-Derived Neurotrophic Factor (BDNF), a protein that can aid in stroke recovery.
"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 neurodegenerative pathways, including elevations of BDNF," said Dr. Rick Strassman, author of 'DMT: The Spirit Molecule' and Algernon consultant. "Such effects may prove beneficial in ischemic stroke patients acutely and in their rehabilitation."
Photo: Benzinga edit with photo by Luis Quintero on Pexels and Harbin on Wikimedia Commons.