Psyched Wellness presented its proprietary extract of the Amanita Muscaria mushroom, AME-1, to Health Canada representatives to discuss the evidence required in support of a Class III Product License Application (PLA).
Earlier this year, life sciences company Psyched Wellness, announced that its Amanita Muscaria mushroom extract, AME-1, demonstrated a potential new functional property of inhibiting human mast cell activation. This functional property could hold promise for common inflammatory skin conditions.
In November, representatives from Psyched Wellness and KGK Science, the company’s contract research organisation (CRO), presented AME-1 to representatives of Health Canada in a pre-submission meeting following Health Canada’s announcement to add Amanita Muscaria mushroom to the Natural Health Products Ingredients Database (NHPID) of Canada.
Speaking after the meeting, CEO of Psyched, Jeffrey Stevens, commented: “Yesterday’s pre-submission meeting was the next important step in positioning the company to be able to file an application with Health Canada for AME-1 as a Natural Health Product in 2022.
“The meeting was very encouraging, and we look forward to incorporating Health Canada’s comments and suggestions into our plans to bring our Amanita-based CPG products to market next year.”
The company has also announced that a full toxicology report of its 90-day oral repeat-dose study with AME-1 and final histopathology report will be published by mid-January 2022. The study examined the effects of Amanita Muscaria on rodents and involved a repeated dose 90-day oral toxicity study of AME-1, the results of which will provide information on the major toxic effects.
It will also provide insights on target organs and the possibility of accumulation of test chemical, and can provide an estimate of a no-observed-adverse-effect level (NOAEL) of exposure which can be used in selecting dose levels for chronic studies and for establishing safety criteria for human exposure.
Stevens said: “The completion of the 90-day oral toxicity study is a major milestone for Psyched as it provides critical scientific data for the determination of safe dosage levels of AME-1, from which all of our consumer products will be derived as we prepare to launch them to market next year.
“Although we are waiting for the final report, we are pleased to share that there was no mortality or morbidity of any of the test rodents during the study and we look forward to providing the full toxicology and histopathology reports early next year.”
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