Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) told investors it has filed a combined Clinical Trials of Investigational Medicinal Products and Ethics Approval application with the UK Medicines and Healthcare Products Regulatory Agency.
The Vancouver-based clinical-stage pharmaceutical development company said the application was accomplished via the combined review service, which provides for a single application route for its planned Phase 1 clinical human study of AP-188 (N, N-dimethyltryptamine or DMT), a known psychedelic compound that is part of the tryptamine family.
The application follows positive feedback at a scientific advice meeting from the UK MHRA for its planned Phase 1 DMT stroke study, the company said, referring to a November 19, 2021, announcement.
READ: Algernon Pharmaceuticals plans to file clinical trial authorisation application for DMT stroke trial as soon as possible after positive feedback from UK regulator
Algernon said the primary focus of the Phase 1 DMT study is to investigate prolonged intravenous infusion of DMT, for durations that have never been clinically studied. The resulting data generated will help it to plan both its Phase 2 acute stroke and rehabilitation studies more effectively, it added.
The first part of the study will use a single-escalating dose design aimed at identifying the maximum sub-psychedelic dose, while the second part will test the effects of repeated administrations of this dose. There will be up to 96 healthy volunteers enrolled across the two parts of the study which will include both psychedelic experienced and psychedelic naïve patients, the company explained.
“We look forward to getting our DMT clinical stroke program started with our Phase 1 study at Hammersmith Medicines Research in the UK,” CEO Christopher Moreau said in a statement.
“This study will provide important information on dosage and duration of our new DMT IV formula to help us better plan for our Phase 2 study where we plan to test the drug with both acute and recovering stroke patients.”
The company noted that it has filed provisional patents for new forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke. It has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint-Induced Movement Therapy.
Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets.
Contact the author at stephen.gunnion@proactiveinvestors.com