Psyched Wellness Ltd (CSE:PSYC) (OTCQB:PSYCF) (FRA:5U9), a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, announced Tuesday that it has received the results from its Maximum Tolerated Dosage (MTD) study of AME-1 conducted by KGK Science.
"I am pleased to share the positive results from the individual studies that our CRO is conducting in the pre-clinical study on our behalf for AME-1," Jeff Stevens, CEO of Psyched Wellness, said in a statement. "Today's results pushes us one step closer to our goal of applying to the FDA for a New Dietary Ingredient and to Health Canada for a Natural Health Product Number."
Psyched Wellness said the study is the first set of thorough toxicology assessments on the company's Amanita Muscaria extract, AME-1. The MTD study summarizes the maximum tolerated dose and LD50 thresholds for AME-1.
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This significant set of information obtained permits for the next step of pre-clinical studies involving a 14- and 90-day oral toxicity to further identify a safe, effective dose for human consumption, the company said.
"This is a key first step in the toxicological assessment of AME-1 that is the foundation for the next set of preclinical studies further identifying the properties of AME-1," said Brian Tancowny, scientific advisor to the company.
"For centuries Amanita Muscaria has been embraced by cultures due to its restorative and rejuvenating qualities and with these results, Psyched Wellness is well on its way to delivering a clinically tested and medically approved product that will effectively treat, repair and nurture the mind, body and soul.”
Psyched Wellness is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods.
The company's objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. It is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas, and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.
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