Algernon has started a clinical research program for stroke focused on AP-188 (“N,N-Dimethyltryptamine or DMT”), a known psychedelic compound that is part of the tryptamine family (other drugs in the tryptamine family include psilocybin and psilocin). Algernon plans to be the first Company globally to pursue DMT for stroke in humans and is planning to begin a clinical trial as soon as possible in 2021.
The Company announced in early January that it would be establishing a new clinical research program in Q1 2021 to add to its current pipeline. Repurposing DMT from its psychedelic effects to a new potential treatment for stroke could have a positive impact on the millions of people that suffer the debilitating consequences of a stroke each year.
The Company’s decision to investigate DMT and move it into human trials for stroke is based on multiple independent, positive preclinical studies demonstrating that DMT helps promote neurogenesis as well as structural and functional neural plasticity. These are key factors involved in the brain’s ability to form and reorganize synaptic connections, which are needed for healing following a brain injury.
A recently published preclinical study in an animal model for stroke, showed that rats treated with DMT recovered motor function more quickly and to a greater extent, and also exhibited lower lesion volumes when compared to control group animals that did not receive DMT. Key data from the study achieved statistical significance.
Unlike other companies recently researching psychedelic drugs, Algernon will be focusing on a sub-hallucinogenic, or microdose of DMT provided by continuous intravenous administration. By pursuing a continuous active microdose, the goal will be to provide patients with the therapeutic benefits of DMT, without having a psychedelic experience. This is an important element when considering treating a patient who has just suffered a stroke, wherein medications that cause a hallucinogenic response would cause unwanted confusion and stress.
The Company also believes that a microdosing approach to developing a DMT treatment may enable a much wider review and acceptance of its data, including garnering the early interest of research investigators, the interest of clinical trial patients, and ultimately clinical acceptance. Algernon’s approach may also allow for a quicker pathway to regulatory approval including a Breakthrough Therapy designation from the U.S. FDA, which enables priority review of a drug candidate if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.