Canadian clinical-stage biotech company Algernon Pharmaceuticals AGNPF announced its plans to move forward with an intravenous (IV) formulation of its DMT-based compound AP-188 for the potential treatment of stroke.
The research program has now become Algernon's lead drug asset, following the sale of its Ifenprodil research program to the U.S. private drug development firm Seyltx this March.
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The company established Algernon NeuroScience -or AGN Neuro- to advance R&D on the DMT stroke program in 2023. The wholly-owned subsidiary completed a feasibility study and has the expected Phase 2a clinical trial design ready that will assess an IV sub-psychedelic dose of DMT in 40 patients under hospitalization following an acute ischemic stroke.
Participants will receive either DMT or placebo; the study's primary outcome measure will be safety. Additional information on efficacy, including preservation of brain tissue, motor recovery, depression and biomarkers linked to stroke's pathophysiology are also expected.
This Phase 2 study follows positive data from the company's Phase 1 clinical trial. Conducted at the CHDR in the Netherlands, findings showed that plasma levels of DMT associated with neuroplasticity in prior, preclinical studies could be achieved with a prolonged 6-hour infusion of DMT at a dose that didn't cause a psychedelic experience.
AGN Neuro says it is the first company worldwide to produce clinical research on DMT for the treatment of stroke and its ability to promote neuroplasticity in the healing of brain injuries.
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"Investigating neuroplasticity in a clinical setting, as a potential new treatment approach for ischemic stroke patients, is a new and promising area of research," said Algernon's CEO Christopher Moreau.
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