Biomind Labs Receives Third Phase II Clinical Trial Approval for its 5-MeO-DMT-Based Candidate BMND08 for the Treatment of Depression and Anxiety in Alzheimer’s Disease


TORONTO–(BUSINESS WIRE)–Biomind Laboratories Inc. (“Biomind Laboratories“or the”Company”) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotechnology company focused on developing the next generation of pharmaceuticals to treat patients with neurological and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules, is pleased to announce that a third Phase II clinical trial for its candidate BMND08 based on 5-Methoxy-N,N-dimethyltryptamine (“5-MeO-DMT”) for the treatment of depression and anxiety in patients with Alzheimer-type cognitive impairment has been approved by the Argentine Institutional Review Board.

“As we continue to move forward with our efforts to identify indications where we can make significant improvement in mentally ill patients, we are more than excited to announce the approval of a phase clinical trial. II for our new drug candidate BMND08 which could allow us to approach a new line of development to alleviate depressive and anxious states in patients with Alzheimer-like cognitive disorders,” commented Alejandro Antalich, CEO of Biomind Labs.

“Since our creation, neurodegenerative diseases have been on the list of indications we wanted to tackle. We can now address these indications using a new approach that uses a fast-acting psychedelic molecule capable of relieving certain mood states when Alzheimer’s disease first appears in patients. After a thorough analysis of the potential benefits of using a psychedelic molecule to relieve certain symptoms in patients with Alzheimer’s disease, we concluded that the most suitable candidate in our portfolio was BMND08, an oral formulation of 5-MeO-DMT.

“Given the significant morbidity associated with Alzheimer’s disease, such as agitation, apathy, sleep disturbances and anxiety, it became clear to us that new approaches to treating Alzheimer’s-like cognitive impairment were urgently needed. The Phase II clinical trial will test Biomind’s psychiatric intervention-based model, enabling rapid and feasible fusion of fast-acting psychedelic drugs into already existing clinical practices.

“It is an honor for us to work with neuroscientist Dr. Martín A. Bruno and a highly professional interdisciplinary medical team who will be responsible for conducting this phase II clinical trial.

“While current practice guidelines consistently point to symptom management as central to the treatment of Alzheimer’s disease, the lack of established effective treatments continues to motivate us to generate new therapeutic solutions,” concluded Antalich.

About Biomind Labs Inc.

Biomind Labs is a biotechnology research and development company focused on transforming biomedical science knowledge into new pharmaceutical drugs and innovative nanotechnology delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs develops new pharmaceutical formulations of the main psychedelic molecules, N,N-Dimethyltryptamine, 5-MeO-DMT and mescaline to treat a wide range of therapeutic indications. Biomind Labs’ goal is to provide patients with access to affordable and modern treatments.

Caution Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as of the date of this press release. Any statement that discusses predictions, expectations, beliefs, plans, projections, goals, assumptions, future events, or performance (often, but not always, using expressions such as “s’ expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “plans”, “estimates”, “believes” or “intends” or variations of these words and phrases or indicating that certain actions, events or results “may” or “might”, “would”, “might” or “will” be assumed to occur or be realized) are not statements of historical fact and may be forward-looking information. Forward-looking statements contained herein include, among others, statements relating to the Company’s ability to scientifically harness the medicinal power of psychedelic molecules to treat patients with neurological and psychiatric disorders, any possible timelines and results of the trial. Phase II clinical trial of the Company’s new drug candidate BMND08, including but not limited to its ability to alleviate depressive and anxiety states in patients with Alzheimer’s-like cognitive disorders and to alleviate certain mental illnesses. mood when Alzheimer’s disease first appears in patients, the Company’s rapid and feasible integration of fast-acting psychedelic drugs into already existing clinical practices, the Company’s ability to provide patients with access to affordable and modern treatments, and other statements that are not historical facts.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements, or other future events, to differ materially from the results, performance or future achievements expressed or implied by such forward-looking statements. These factors and risks include, among others: (a) the Company may need additional funding from time to time in order to continue its operations which may not be available when needed or on acceptable terms; (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) stock markets have experienced volatility that has often been unrelated to business performance and such fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in public perception of tryptamine treatments and psychedelic 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 regarding the products offered by the Company. The United States Food and Drug Administration, Health Canada, or other similar regulatory authorities have not evaluated claims regarding tryptamine treatments, psychedelic therapies, or other psychedelic compounds. The effectiveness of these products has not been confirmed by approved research. There is no guarantee that the use of psychedelic tryptamines, tryptamine derivatives, or other psychedelic compounds will 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 the products it offers. Any reference to the quality, consistency, efficacy and safety of potential products does not imply that the Company has verified it in commercial clinical trials or that it will complete such trials. Failure of the Company to obtain the necessary approvals or research to commercialize its business could have a material adverse effect on its performance and business.

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

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


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