A Foundational Study On Stroke Is Ready. Here Is Why It's Important

Biopharma company Algernon Pharmaceuticals Inc's AGNPF recently announced plan for a Phase 1 clinical study on DMT for human stroke has just received approval from the Stichting Beoordeling Ethiek Biomedisch Onderzoek (BEBO), an independent Medical Research Ethics Committee. 

The trial will be conducted at the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, with screening beginning shortly and dosing expected to start in the fourth quarter of 2022.

With the center having previously led DMT studies, Algernon had initially retained the CHDR and its affiliated pharmacy at the Leiden University Medical Center to develop the IVF destined for the Phase 1 study. The partners then decided to move forward with an ethics and clinical trial application in order to advance the DMT stroke research program in the fastest manner possible.

The focus of the research is grounded in the findings of several preclinical studies which have already demonstrated this particular psychedelic helps mitigate tissue damage and promotes neurogenesis as well as structural and functional neural plasticity, all key factors involved in the brain’s ability to form and reorganize synaptic connections and therefore helping the brain heal after an injury. 

In addition, Algernon’s murine cortical neuron outgrowth preclinical study showed that sub-psychedelic doses of DMT increased the growth of cortical neurons by up to 40%.

Also Read: DMT Producer PsyBio And Shrooms Grower Red Light Holland Share Their Most Recent Financial Results

Previous Phase 1 DMT studies were positive, therefore no serious adverse events or safety issues are anticipated to arise from the present study. Nonetheless, Algernon is conducting a Phase 1 and not directly advancing into a Phase 2 study because the hub of the research is on prolonged intravenous infusion of DMT, durations not yet clinically studied. 

The resulting data from this study is expected to help the company to better plan Phase 2 acute stroke and rehabilitation studies, providing “important information on dosage and duration of our new DMT IVF formula to help us better plan for our Phase 2 where we plan to test the drug with both acute and recovering stroke patients,” Algernon’s CEO Christopher J. Moreau explained.

The company has a team of world-class psychedelics consultants backing this new research. Author of the best-selling book “DMT: The Spirit Molecule”, psychiatrist and psychopharmacologist Dr. Rick Strassman stated: “I was drawn to DMT’s endogenous nature and possible role in naturally-occurring altered states of consciousness such as dreams and psychosis, as well as being a prototype for other psychedelic drugs in common use.”

Strassman conducted the first new American clinical research with psychedelic drugs from 1990 to 1995. The Phase 1 DMT trial, funded by the National Institutes of Health (NIH) and developed at the University of New Mexico, assessed biological and psychological effects in normal volunteers and demonstrated the safety of clinical psychedelic studies. 

As the author and consultant further explained, “Our careful assessment of psychedelic and non-psychedelic doses of DMT established guidelines for studies utilizing its neuroplastogenic effects in stroke, an application I would not have predicted at the time. These more recent findings of DMT’s effects have opened an extraordinarily promising set of potential therapeutic applications for Algernon to explore.”

On the present study, professor of neuropsychopharmacology at Imperial College London and Algernon’s consultant Dr. David Nutt detailed that although it will be performed with “healthy volunteers, the protocol includes study of some markers which may give some early clues about potential benefits in stroke victims.”

Algernon’s commercialization strategy has led the company to file patents for DMT pamoate and nicotinate (novel salt forms of DMT), for formulation, dosage and method of use claims for ischemic stroke, and for the combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy.

Photo courtesy of RF._.studio on Pexels and Wikimedia Commons.