Algernon Pharmaceuticals Inc Receives Positive Feedback From U.S. Food and Drug Administration For Its DMT Stroke Program

Algernon Pharmaceuticals Inc (CSE: AGN) (OTCQB: AGNPF) (FRA: AGW) said it has received positive feedback from the United States Food and Drug Administration (FDA) on its plans to investigate the use of DMT in treatment of stroke.

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 physiotherapy program for stroke rehabilitation.

Algernon submitted a pre-investigational new drug (IND) application 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 experiences and offered advice regarding supporting preclinical safety studies.

Additionally, the FDA provided “valuable input” to the design of Algernon’s planned Phase 1 clinical trial, which is expected to begin in the fourth quarter of 2021.

“On February 1, 2021, Algernon announced that it plans to be the first company in the world to test DMT in human clinical trials for stroke, and this is a goal we are actively pursuing,” said Christopher Moreau , CEO of Algernon, to investors.

“While we will begin by studying DMT as an adjunct to physiotherapy in the rehabilitation of stroke patients, we are currently engaged in preclinical research which will also inform us about our planned Phase 2 for ischemic stroke. Algernon will file an additional pre-IND meeting request with the FDA for its planned ischemic stroke program when its preclinical research program is completed.

The company has filed provisional patents for new forms of DMT in stroke therapy, as well as claims for a combination therapy of DMT and strain-induced movement therapy.

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