Biomind Labs Announces the Start of the First-Ever Clinical Trial Targeting Depression and Anxiety in Alzheimer’s Disease With a Proprietary formulation Based On 5-MeO-DMT

TORONTO–(BUSINESS WIRE)–Biomind Labs Inc. (“Biomind Labs” or the “Company”) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological disorders by targeting the drivers of disease, is pleased to announce that it has commenced a Phase II clinical trial for its proprietary 5-Metoxi-N,N-dimethyltryptamine (“5-MeO-DMT“)-based BMND08 candidate, a sublingual formulation for the potential treatment of anxiety and depression in Alzheimer’s disease.

“The burden of Alzheimer’s disease and related dementias is already costing trillions of dollars to the global economy¹, and an aging population is an exacerbating factor. This burden may be decreased by a radical and fast intervention that goes beyond traditional and conventional treatments in order to tackle this silent and hidden neurological disease. The Phase IIa, double-blind, randomized, placebo-controlled, repeated single dose trial, is being led by our Clinical Advisor Neuroscientist Dr. Martín Bruno, includes 40 subjects (50-75 years old) and is being carried out at Dr. Marcial Quiroga Hospital in Argentina,” commented Alejandro Antalich, CEO of Biomind Labs.

“Biomind’s trial aims to clarify the clinical profile of anxiety and depression and its association with Alzheimer’s disease in community samples of Amnestic Mild Cognitive Impairment, evaluating whether progression to Alzheimer’s disease can be delayed through routine monitoring and timely management of anxiety and depressive symptoms. Amnestic Mild Cognitive Impairment is characterized by memory impairment with preservation of functional independence and is considered a transitional stage between normal aging and Alzheimer’s disease. However, rates of conversion to Alzheimer’s disease are highly variable. While 10-15% of Amnestic Mild Cognitive Impairment convert to Alzheimer’s disease within a year, others remain stable or improve in memory performance. Neuropsychiatric symptoms, such as anxiety and depression, are frequent in Amnestic Mild Cognitive Impairment. Both symptoms in Amnestic Mild Cognitive Impairment patients predict conversion to Alzheimer’s disease, over and beyond the effects of memory loss, poor sleep, use of psychotropic medications or atrophy within Alzheimer’s disease neuroimaging biomarkers,” commented Dr. Martín Bruno, Clinical Advisor of Biomind Labs.

Currently more than 55 million people have dementia worldwide with this number anticipated to almost double every 20 years, reaching 78 million in 2030 and 139 million in 2050. Much of the increase will be in developing countries. Already 60% of people with dementia live in low- and middle-income countries, but by 2050 this will rise to 71%. The fastest growth in the elderly population is taking place in China, India, and their south Asian and western Pacific neighbors. Dementia results from a variety of diseases and injuries that affect the brain. Alzheimer disease is the most common form of dementia and may contribute to 60–70% of cases. ^{(2) (3)}

About Biomind Labs Inc.

Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of N, N-dimethyltryptamine (“DMT”), 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to provide patients access to affordable and modern-day treatments.

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The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The United States Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments, psychedelic-based therapies or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psychedelic tryptamines, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed commercial clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in commercial clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

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¹ eClinicalMedicine. September 2022; 51: 101580, PMCID: PMC9310134.

² World Health Organization, March 15, 2023, Fact sheets “Dementia”.

³ World Alzheimer Report 2021, September 21, 2021, Alzheimer’s Disease International, McGill University.

Contacts

For more information, please contact:

Biomind Labs Inc.

Alejandro Antalich

Chief Executive Officer

Email: [email protected]
Tel: + 598 97 702500