VANCOUVER, British Columbia, June 17, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) is pleased to announce that all of the required permits and licenses for the manufacture of its cGMP supply of AP-188 (“N, N-Dimethyltryptamine or DMT”) have been received and as a result, is targeting its Phase 1 human study to be conducted at Hammersmith Medicines Research UK in Q4, 2021. The Company awarded the contract to manufacture the active pharmaceutical ingredient and finished product for its formulation of DMT, to Canadian-based Dalton Pharma Services.
The planned Phase 1 study will investigate the safety, tolerability and pharmacokinetics of intravenous DMT infusion in healthy volunteers with no prior history of psychedelic exposure. Specifically, the trial will aim to identify a sub-hallucinogenic dosing regimen to support planned clinical studies in stroke patients.
The Company is also pleased to announce that its first preclinical study, with research grade DMT, is now underway with Charles River Laboratories (“Charles River”). The in vitro experiments will provide information on the duration and dose of infusion needed to achieve maximal cortical neurite outgrowth as well as the underlying mechanism of the drug’s action. These experiments will also inform the design of confirmatory animal stroke studies also planned at Charles River and scheduled for later this year. The Charles River site in Kuopio, Finland is recognized as a world leader for preclinical stroke studies.
“While there are many companies that are working in or attempting to enter the psychedelic drug space, many are a considerable distance from human studies,” said Christopher J. Moreau, CEO of Algernon pharmaceuticals. “We announced that we plan to be the first company globally to investigate DMT for stroke and that is a goal that we are getting closer to achieving.”
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 well-tolerated, 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. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.
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 any of the included forward-looking statements as expressly required by applicable law.