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Algernon NeuroScience (AGN Neuro), a subsidiary of Algernon Pharmaceuticals Inc. (OTCQB:AGNPF) (CSE:AGN) (FRANKFURT:AGW0), has completed a feasibility study and has finalized its clinical trial design for a 40 patient phase 2 DMT stroke study. The phase 2 human stroke trial will study an intravenous sub-psychedelic dose of DMT in patients who are hospitalized after having suffered an acute ischemic stroke.
The decision to investigate DMT for stroke treatment was based on the ground-breaking 2020-published rat occlusion stroke study showing that DMT reduced infarct volume and led to an almost full recovery of motor function 30 days after a single treatment with statistical significance. This was also one of numerous pre-clinical studies that showed DMT increases brain derived neurotropic factor, the main neurotrophin involved in healing the brain after an injury. DMT activates pathways involved in forming neuronal connections and has been shown to increase the capacity of neurons to form new neural connections by expanding cell morphology and the growth of dendritic spines; the sites of signal transduction between neurons. DMT has also been shown to protect at risk tissue from death, a process AGN Neuro plans to capitalize on by providing the drug in the acute period before damage has a chance to substantially expand.
AGN Neuro is planning to conduct the study at multiple locations in Europe using the company’s existing finished product supply of intravenous DMT. Ethics submission is planned for later in Q3 with the study starting a short time after approval.
Phase 2 Stroke Study Design
Subjects with a confirmed diagnosis of ischemic stroke will be randomized in blinded fashion to receive either DMT or placebo. The primary outcome measure of the study will be safety, and information will be gained on measures of efficacy including preservation of brain tissue, motor recovery, depression and numerous biomarkers linked to the pathophysiology of stroke.
The decision to advance into a phase 2 study was based on positive data from the company’s phase 1 trial conducted at the Centre for Human Drug Research in Leiden, Netherlands. This study showed that plasma levels of DMT associated with neuroplasticity in preclinical studies could be achieved with a prolonged, 6-hour infusion of AP-188 at a dose which did not cause a psychedelic experience. The amount given exceeded the human equivalent of the dose used in preclinical studies in rats which demonstrated neuroprotective effects.
Price Action
Algernon Pharmaceuticals shares were trading 7.67% lower at $0.13 per share at the time of writing Tuesday morning.
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