Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) said its subsidiary Algernon NeuroScience (AGN Neuro) has completed dosing of the second cohort in its escalating dose Phase 1 clinical study of an intravenous formulation of AP-188 (N,N-Dimethyltryptamine or DMT).
The company said AGN Neuro also reported that the safety review committee has approved moving the study forward with the final cohort at an escalated dose after observing no safety or tolerability issues.
“This is another important step in our DMT clinical research program,” Algernon Pharmaceuticals CEO Christopher Moreau said in a statement. “The sooner we can finalize the correct dose and the optimum exposure period, the faster we can move into Phase 2 studies where we can test DMT on patients that have suffered a serious brain injury.”
READ: Former NFL neurologist joins Algernon's program using DMT to treat traumatic brain injury
The company noted that the trial is being conducted at the Centre for Human Drug Research (CHDR) in Leiden, Netherlands.
The purpose of the study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by a prolonged infusion of six 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, will be recorded.
The company said it is working with its top stroke and traumatic brain injury (TBI) experts to design Phase 2 studies for the continued investigation of DMT.
DMT is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazon basin. DMT can also be synthesised in a laboratory.
AGN Neuro is a private equity subsidiary of Algernon Pharma and has been created to advance the company’s DMT stroke research program. AGN Neuro has filed a Form 1-A offering statement with the US Securities and Exchange Commission (SEC), seeking qualification to raise up to US$10 million for AGN Neuro by offering up to 37.5% of its common shares (including the maximum amount of bonus shares), with majority ownership residing with AGN Pharma, under a Tier II Regulation A+ offering.
Algernon Pharma is a Canadian clinical-stage drug development and repurposing company investigating multiple drugs for unmet global medical needs. It also has active research programs for IPF with chronic cough, and chronic kidney disease.
Contact the author at stephen.gunnion@proactiveinvestors.com