Algernon Pharmaceuticals says NeuroScience unit doses first subject in Phase 1 DMT clinical stroke study Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) told investors that its subsidiary, Algernon NeuroScience (AGN Neuro), has dosed the first subject in its Phase 1 clinical study of an intravenous formulation of AP-188 (N,N-Dimethyltryptamine or DMT) at the Centre for Human Drug Research in Leiden, Netherlands. The company said DMT is a known psychedelic compound that is part of the tryptamine family and is an agonist of multiple receptors, including serotonin receptors and the sigma-1 receptor. Sigma-1 is a multi-faceted stress-responsive receptor that promotes cell survival, neuroprotection, neuroplasticity, and neuroimmunomodulation, it added. Further, it noted that 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 neuroregenerative pathways, including elevations of BDNF,” Dr Rick Strassman, author of 'DMT: The Spirit Molecule' and an Algernon consultant said in a statement. “Such effects may prove beneficial in ischemic stroke patients acutely and in their rehabilitation.” READ: Algernon Pharmaceuticals forms private subsidiary to advance psychedelic DMT stroke program 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 added: “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,” Nutt continued. Algernon explained that the purpose of the Phase 1 study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by a prolonged infusion, for durations that have never been studied clinically. In addition, several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, will be recorded. Identifying a safe and tolerable dose 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 same dose. There will be up to 60 healthy volunteers enrolled across the two parts of the study, which will include both psychedelic-experienced and psychedelic naïve patients. Since there have already been several Phase 1 studies successfully conducted on DMT, Algernon said it does not anticipate any serious adverse events or safety issues arising from the study. The resulting data generated will help it to plan both a Phase 2 acute stroke and rehabilitation study more effectively, it added. The company said 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,” Algernon Pharmaceuticals CEO Christopher Moreau concluded. “We anticipate receiving data from this study in 3Q 2023, and potentially beginning Phase 2 studies in stroke patients by the end of the calendar year.” The company said it has filed patents for DMT pamoate and nicotinate (novel salt forms of DMT), in addition to formulation, dosage and method of use claims for ischemic stroke. The company has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy. Algernon NeuroScience is a private equity subsidiary of Algernon Pharmaceuticals and has been created to advance the company’s DMT stroke research program. Algernon Pharmaceuticals is a Canadian clinical-stage drug development and repurposing company investigating multiple drugs for unmet global medical needs. The company has active research programs for IPF with chronic cough, and chronic kidney disease.
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