Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) (FRA:AGW) said it had received positive feedback from the US Food and Drug Administration (FDA) on its plans to investigate the use of DMT in stroke treatment.
The pharmaceutical company is researching AP-188 (N,N-Dimethyltryptamine, or DMT), a psychedelic compound that is part of the tryptamine family, as part of a physical therapy program in the rehabilitation of stroke.
Algernon submitted a pre-investigational new drug (IND) request in March 2021 to the FDA.
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In a statement, Vancouver-based Algernon said the FDA agreed with its planned preclinical efficacy experiments and offered guidance with regards to supportive preclinical safety studies.
In addition, the FDA provided “valuable input” into the design of Algernon’s planned Phase 1 clinical trial, which is set to begin in the fourth quarter of 2021.
“On February 1, 2021, Algernon announced that it was planning to be the first company in the world to test DMT in human clinical trials for stroke, and that is an objective we are aggressively pursuing,” Algernon CEO Christopher Moreau told investors.
”While we will begin with investigating DMT as an adjunct to physical therapy in the rehabilitation of stroke patients, we are currently engaged in preclinical research that will inform us on our planned Phase 2 for ischemic stroke as well. Algernon will file an additional Pre-IND meeting request with the FDA for its planned ischemic stroke program when its preclinical research program is complete.”
The company has filed provisional patents for new forms of DMT in stroke therapy, as well as claims for combination therapy of DMT and Constraint-Induced Movement Therapy.
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