Algernon Announces Positive Feedback on its Planned Phase 1/2a DMT Human Stroke Study
Algernon Pharmaceuticals has received positive feedback from the UK MHRA regarding its Phase 1/2a stroke study utilizing AP-188 (DMT). The Company plans to file a Clinical Trial Authorization and is considering DMT for acute stroke treatment. The study aims to investigate DMT's efficacy as both a primary treatment and an adjunct for rehabilitation. Conducted at Hammersmith Medicines Research in London, the trial is scheduled to commence in January 2022.
- Received positive feedback from UK MHRA, indicating regulatory support.
- Plans to file Clinical Trial Authorization for the Phase 1/2a stroke study.
- Intends to investigate DMT as a potential acute stroke treatment and adjunct therapy.
- None.
VANCOUVER, British Columbia, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) a clinical stage pharmaceutical development company, is pleased to announce that it has received positive feedback at a scientific advice meeting from the United Kingdom Medicines and Healthcare Products Regulatory Agency (“UK MHRA”). The scientific advice meeting was related to the Company’s planned Phase 1/2a stroke study with AP-188 (“N,N-dimethyltryptamine” or “DMT”), a known psychedelic compound that is part of the tryptamine family.
As a result of the meeting, the Company plans to file a Clinical Trial Authorisation (CTA) application for the study as soon as possible. In addition, and based on the feedback received, the Company is also considering focussing on DMT as a possible treatment for acute stroke for the Phase 2a part of the study, in addition to investigating DMT as an adjunctive treatment for stroke rehabilitation therapy.
The Company is planning to conduct the Phase 1 part of the study at Hammersmith Medicines Research in London, UK and is now targeting to begin the study in January 2022.
“We were very encouraged by today’s meeting with the UK MHRA,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “The feedback we received was very helpful and we look forward to working with the agency as we move forward with the important work of investigating DMT as a possible therapy for stroke patients globally.”
About DMT
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 and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazonian basin. DMT can also be synthesised 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 Constraint Induced Movement Therapy.
About Algernon Pharmaceuticals Inc.
Algernon is a drug re-purposing company that investigates safe, already approved drugs, and 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. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.
CONTACT INFORMATION
Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly
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