Algernon Pharmaceuticals Inc (CSE:AGN) (FRA:AGW) (OTCQB:AGNPF) has announced that all of the required permits and licenses for the manufacture of its AP-188 (N, N-Dimethyltryptamine or DMT) have been received.
As a result, the company said it is targeting its Phase 1 human study to be conducted at Hammersmith Medicines Research in the UK in the fourth quarter of 2021.
Algernon said it awarded the contract to manufacture the active pharmaceutical ingredient and finished product for its formulation of DMT to Canada-based Dalton Pharma Services.
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The Vancouver-based company said the planned Phase 1 study will investigate the safety, tolerability, and pharmacokinetics of intravenous DMT infusion in healthy volunteers with no prior history of psychedelic exposure. Specifically, the trial will aim to identify a sub-hallucinogenic dosing regimen to support planned clinical studies in stroke patients.
Meanwhile, Algernon also announced that its first preclinical study with research-grade DMT is now underway with Charles River Laboratories. The site in Kuopio, Finland is recognized as a world leader for preclinical stroke studies.
The company said the in vitro experiments will provide information on the duration and dose of infusion needed to achieve maximal cortical neurite outgrowth as well as the underlying mechanism of the drug’s action. These experiments will also inform the design of confirmatory animal stroke studies also planned at Charles River and scheduled for later this year.
“While there are many companies that are working in or attempting to enter the psychedelic drug space, many are a considerable distance from human studies,” said Algernon CEO Christopher Moreau in a statement. “We announced that we plan to be the first company globally to investigate DMT for stroke and that is a goal that we are getting closer to achieving.”
Algernon has filed provisional patents for new 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 Constraint-Induced Movement Therapy.
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