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.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this document include, among others, statements relating to the Company’s ability to scientifically harness the medicinal power of psychedelic molecules to treat patients suffering from neurological and psychiatric disorders, the impact of new treatments on addressing the burden of Alzheimer’s disease and related dementias; the Company’s statements regarding the Phase II trial of the Company’s novel drug candidate BMND08; the Company’s ability to provide patients access to affordable and modern-day treatments; and other statements that are not historical facts.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company’s business and results of operations; (d) the stock markets have experienced volatility that often has been unrelated to the performance of companies and these fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in the public perception of tryptamine-based treatments and psychedelic-based therapies; (f) the impact of COVID-19; and (g) general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release.

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.

The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

The Neo Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230425005788/en/