Canadian Psychedelics Company To Begin First Global DMT Clinical Trial For Stroke Treatment

Algernon Pharmaceuticals Inc. AGNPF has set up a clinical research program for the treatment of strokes, focused on its proprietary DMT analogue, AP-188. The company is also planning to begin a Phase 1 clinical trial in 2022’s fourth quarter.

The decision to focus research on DMT for stroke treatment came after preclinical studies showed that DMT helps promote neurogenesis as well as structural and functional neural plasticity, which are key factors within the brain’s ability to make and reorganize synaptic connections after an injury.

In terms of progress, Algernon has completed its intravenous formulation (IVF), developed by the Centre for Human Drug Research (CHDR) and its affiliated pharmacy at the Leiden University Medical Center in the Netherlands. It has applied for ethics and clinical trial approval for its use in the Phase 1 study.

The purpose of this planned trial is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion. A single-escalating dose design will first be used, following a second part to test the effects of repeated administrations of the highest safe dose. 

Up to 60 healthy volunteers, including both psychedelic experienced and naïve patients, will be enrolled across the two parts of the study.

Algernon’s Focus

Algernon is a drug repurposing company that investigates safe, already approved drugs for new disease applications, developing novel formulations and seeking global markets’ regulatory approvals. 

The company also specifically targets compounds that have never been approved in the U.S. or Europe in order to avoid off label prescription writing.

As for DMT (short for N,N-Dimethyltryptamine), it is a natural-occurring hallucinogenic tryptamine drug whose effects are similar to those of LSD, ketamine, psilocybin and psilocin. The compound, which has been historically used in religious ceremonies as a traditional spiritual medicine, occurs naturally in plant species as well as animals -including humans- and can also be synthesized in a lab.

Algernon has filed provisional patents for new salt forms of DMT, for formulation, dosage and method of use claims for ischemic stroke, and for the therapy pairing DMT and stroke rehabilitation including constraint induced movement therapy.

Photo courtesy of Pavel Danilyuk on Pexels and Harbin on Wikimedia Commons.