Algernon Pharmaceuticals Inc. (CSE: AGN) (OTCQB: AGNPF)announced that its subsidiary Algernon NeuroScience (AGN Neuro), has successfully completed dosing of the third and planned final cohort in its escalating dose Phase 1 clinical study of an intravenous (IV) formulation of AP-188 (DMT). AGN Neuro is the world’s first company to investigate DMT for both the treatment of stroke and traumatic brain injury (TBI).
In pre-clinical studies, DMT has been demonstrated to increase brain derived neurotropic factor (BDNF) which is believed to be a key mechanism involved in healing the brain after an injury. According to the company’s statement, DMT is believed to activate pathways involved in forming neuronal connections and has been shown to increase the number of dendritic spines on cortical neurons. Dendritic spines form synapses (connections) with other neurons and are a critical site of molecular activity in the brain.
“Neuroplasticity’s role in healing the brain after an injury is one of the most exciting areas of research going on globally in the pursuit of a treatment for stroke and TBI, and AGN Neuro is at the forefront of this work,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “Now that we have established the safety of a single sub psychedelic dose of DMT, we are planning to accelerate our DMT Phase 2 studies accordingly, for both stroke and TBI.”
AGN Neuro also reported that the safety review committee has confirmed that there were no safety or tolerability issues with the highest dose, which was able to maintain plasma DMT concentrations at targeted levels and which was below the established psychedelic dose. AGN Neuro is the first company to test DMT at single escalating concentrations with an IV dose for a 6-hour duration.
The single escalating dose Phase 1 trial was conducted at the Centre for Human Drug Research in Leiden, Netherlands. The purpose of the study was to identify the safety, tolerability, and pharmacokinetics of sub-psychedelic doses of DMT when administered as an intravenous bolus followed by a prolonged infusion of 6 hours, a period which has never been studied clinically. In addition, several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, were recorded. AGN Neuro plans to publish the data from the study in an upcoming issue of a peer reviewed, scientific publication.
Based on the success of the highest tested dose, the second part of the study, which will be scheduled to begin at a later time, will include dosing subjects for 6 hours with repeated administrations over a two-week period. AGN Neuro has now established a single dose regimen which can now be used in its first Phase 2 study for stroke and TBI.