Algernon Pharmaceuticals submits pre-investigational new drug meeting request with US FDA for its DMT stroke research program

Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) (FRA:AGW) has started formal communication with the US regulator, the Food and Drug Administration (FDA), over its previously announced stroke clinical research program.

The company said it had now filed a pre-IND (Investigational New Drug) meeting request with the agency about its investigation of psychedelic compound DMT as a treatment for stroke.

READ: Algernon Pharmaceuticals updates on timing of topline results for Ifenprodil trial

Specifically, it is asking for direction regarding the use of DMT as an adjunctive treatment with constraint-induced movement therapy (CIMT) to treat upper-limb dysfunction in stroke patients.

Another pre-IND meeting request for its use to treat acute stroke will be filed once additional preclinical work is completed, added Algernon.

CIMT is a therapy, which involves intensive training of the weaker limb while restricting the stronger limb, and has shown it can enhance recovery in patients post-stroke.

CIMT is also used in the treatment of other movement disorders, including traumatic brain injury, multiple sclerosis, and Parkinson’s disease.

Unlike other companies researching such drugs, Algernon has said it will focus on a sub-hallucinogenic, or microdose of DMT given via continuous intravenous administration -  the aim being the patient will not have a psychedelic experience. 

The company has noted that this approach may also allow for a quicker pathway to regulatory approval, including a Breakthrough Therapy designation from the US FDA.

On March 1 this year, Algernon reported that a Phase 1 study on the psychedelic compound DMT to treat stroke will be carried out by London-based contract research organization (CRO) Hammersmith Medicines Research (HMR).

The Phase 1 study is anticipated to begin as soon as the company has cGMP drug product from its recently appointed manufacturer Dalton Pharma and will evaluate the safety, tolerability and pharmacokinetics of the proposed sub-psychedelic DMT dosages in healthy participants with no prior history of psychedelic exposure. It will provide essential data on the proposed dosing regimen, and also inform the design of the planned Phase 2 trials.

Algernon also recently hired Charles River Laboratories to conduct its preclinical studies of DMT for the stroke research program.

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