Psyched Wellness (CSE:PSYC, OTCQB:PSYCF) Ltd. has announced the key results from a 90-day oral toxicity preclinical study on its proprietary extract of the Amanita Muscaria mushroom (AME-1), with its contract research organization (CRO) partner.
The Toronto-based company noted that the study was the third set of a group of thorough assessments on AME-1 conducted to determine the systemic toxicity potential of the Amanita Muscaria extract when administered once daily for 90 consecutive days, and summarizes the NOAEL (No Observed Adverse Event Level).
"This is the final step in the toxicological assessment of AME-1 that will form the foundation for the effective safe dose for human consumption and provides the necessary information for any future clinical studies," the company’s scientific advisor Brian Tancowny said in a statement.
"With no adverse effect reported over the period, the study results reinforce our earlier findings about AME-1's safety and allows continued development of our products for human consumption," he added.
READ: Psyched Wellness reports additional positive results from preclinical oral toxicity study of Amanita Muscaria (AME-1)
A summary of the key findings in the report are as follows:
- No adverse clinical signs of toxicity and neither mortality nor morbidity observed in both genders for vehicle and test item treated animals during the study period.
- No treatment-related adverse effects on body weight and normal body weight gain were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
- No treatment-related adverse effects on feed consumption were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
- No treatment-related adverse effects on hematology parameters, coagulation, clinical chemistry, gross necropsy, and organ weights. All parameters studied were found to be normal during the duration of the study period.
- No observed adverse event level occurred. This significant set of information obtained has resulted in the determination of the NOAEL and thus identified the safe effective dose for human consumption.
"In addition to undertaking the 90-day toxicity study, Psyched has been focused on preparing the Self-Gras dossier which will position the company to be able to sell products into the US market and generate revenues in the first half of 2022,” Psyched Wellness (CSE:PSYC, OTCQB:PSYCF) CEO Jeffrey Stevens added.
“Our CRO partner was diligent in updating us on preliminary results throughout the study, advising that there were no findings of concern being recorded. We were very pleased that there were no adverse effects found in the toxicity study, and are grateful to our investors for their patience while the report was being finalized.”
Psyched Wellness (CSE:PSYC, OTCQB:PSYCF) is a 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.
Contact the author at stephen.gunnion@proactiveinvestors.com