- Algernon Pharmaceuticals (AGN) has filed a scientific advice meeting request with the MHRA regarding a Phase 1/2a stroke study with AP-188
- Algernon will confirm that its chemistry, manufacturing and controls information, pre-clinical data, and Phase 1/2a clinical plans are appropriate for a Clinical Trial Authorisation (CTA) application, planned for Q4 of this year
- Phase 1 will investigate the safety, dosage, and pharmacokinetics of DMT
- Phase 2a part will focus on the use of DMT for the treatment of upper-limb dysfunction in stroke patients
- N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin
- Algernon is a drug re-purposing company that investigates safe, already approved drugs, and naturally occurring compounds, for new disease applications
- Algernon Pharmaceuticals Inc. (AGN) opened trading at C$0.085 per share
Algernon Pharmaceuticals (AGN) has filed a scientific advice meeting request with the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA).
The meeting is in regards to a Phase 1/2a stroke study with AP-188 (“N,N-dimethyltryptamine” or “DMT”), a known psychedelic compound that is part of the tryptamine family.
The MHRA encourages companies to seek scientific advice before beginning clinical trials in the UK. These meetings are similar to the pre-IND meetings offered by the U.S. Food and Drug Administration. Through this process, Algernon will confirm that its chemistry, manufacturing and controls information, pre-clinical data, and Phase 1/2a clinical plans are appropriate for submission of a Clinical Trial Authorisation (CTA) application for a study with DMT in the UK.
Submission of the CTA application is planned for Q4 of this year. The Phase 1 portion will investigate the safety, dosage, and pharmacokinetics of DMT, while the Phase 2a part will focus on the use of DMT as an adjunctive treatment to Constraint-Induced Movement Therapy (“CIMT”) for the treatment of upper-limb dysfunction in stroke patients.
During the Phase 1 study of DMT, Algernon will also be able to evaluate if a sub hallucinogenic dose of DMT could be used for the treatment of hemorrhagic stroke patients in addition to patients who have suffered an ischemic stroke. This would be a significant discovery and could lead to a clinical trial to evaluate if patients would benefit from DMT shortly after their stroke has occurred.
The company recently confirmed, in its own in vitro preclinical study, that DMT increased the growth of cortical neurons by 40 per cent with statistical significance in one arm of the study, when compared to control. Algernon also reports that the increased growth was achieved with a sub hallucinogenic dose.
Christopher J. Moreau, CEO of Algernon Pharmaceuticals commented on the upcoming discussions with the MHRA.
“We are pleased to initiate formal discussions of our clinical plans for DMT with the MHRA. The MHRA’s familiarity with DMT means the agency is well-positioned to advise the Company on its clinical research program.”
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. DMT can also be synthesized in a laboratory.
Algernon has filed provisional patents for new 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 CIMT.
Algernon is a drug re-purposing company that investigates safe, already approved drugs, and naturally occurring compounds, for new disease applications.
Algernon Pharmaceuticals Inc. (AGN) opened trading at C$0.085 per share.