Mr. Christopher Moreau reports
ALGERNON NEUROSCIENCE ANNOUNCES SUCCESSFUL DOSING OF 2ND COHORT IN PHASE 1 DMT CLINICAL STUDY
Algernon Pharmaceuticals Inc.'s 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). AGN Neuro also reports 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.
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 that 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.
Once the correct dose has been established in the first part of the study, the second part of the study will include dosing subjects for six hours, with repeated dosing over a two-week period. There will be up to 60 healthy volunteers enrolled in total, which will include both psychedelic-experienced and psychedelic-naive subjects.
The company is working with its top stroke and traumatic brain injury (TBI) experts to design phase 2 studies for the continued investigation of DMT.
"This is another important step in our DMT clinical research program," said Christopher J. Moreau, chief executive officer of Algernon Pharmaceuticals. "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."
N,N-dimethyltryptamine, or 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 synthesized in a laboratory.
Algernon has filed patents for DMT pamoate and nicotinate (novel salt forms of DMT), in addition to formulation, dosage and method of use claims for ischemic stroke. The company has also filed claims for combination therapy of DMT and stroke rehabilitation, including constraint-induced movement therapy.
About Algernon NeuroScience
Algernon NeuroScience is a private equity subsidiary of Algernon Pharmaceuticals and has been created to advance the company's DMT stroke and traumatic brain injury (TBI) research program. AGN Neuro has filed a Form 1-A offering statement with the U.S. Securities and Exchange Commission, which was qualified on March 8, 2023, to raise up to $10-million (U.S.) for AGN Neuro by offering up to 37.5 per cent of its common shares (including the maximum amount of bonus shares), with majority ownership residing with Algernon Pharmaceuticals, under a Tier II Regulation A+ offering.
About Algernon Pharmaceuticals Inc.
Algernon Pharmaceuticals is a Canadian clinical-stage drug development and repurposing company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals has active research programs for IPF (idiopathic pulmonary fibrosis) with chronic cough and chronic kidney disease and is the parent company of a newly created private subsidiary called Algernon NeuroScience, which is advancing a psychedelic program investigating a proprietary form of psychedelic DMT for stroke and TBI.
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