Biomind Labs Announces the Completion of the First Sublingual Psychedelic Formulation for Its Drug Candidate BMND08 for Depression and Anxiety in Alzheimer’s Disease

Rhea-AI Summary

Biomind Labs has developed a novel sublingual formulation for its 5-MeO-DMT-based drug candidate BMND08, aimed at treating depression and anxiety in Alzheimer's patients. This formulation is designed for easier administration, especially in geriatric patients with swallowing difficulties. The company plans to begin its Phase II trial shortly after the initial batch is delivered. CEO Alejandro Antalich emphasizes the importance of addressing neurodegenerative diseases, highlighting the potential for improving patients' quality of life.

Positive

• Successful development of a novel sublingual formulation for BMND08.
• Addresses patient needs, particularly for those with swallowing difficulties.
• Aims to tackle depression and anxiety in Alzheimer's patients, a significant market.

Negative

• Uncertainty about trial outcomes; success in Phase II is not guaranteed.
• Potential regulatory hurdles in bringing the product to market.

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 and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules, is pleased to announce that it has successfully completed the development of a novel sublingual formulation to be used in the Phase II trial for its 5-Metoxi-N,N-dimethyltryptamine (“5-MeO-DMT”)-based BMND08 candidate for the potential treatment of depression and anxiety in Alzheimer’s disease.

“A new milestone achieved that strengthens our vertically integrated strategy. Our scientific team has completed the challenging development of our proprietary sublingual formulation containing 5-MeO-DMT and the production of the first batch to be used in the Phase II trial. We are extremely excited about our novel drug candidate which may allow us to address a new line of development to attenuate depression and anxiety states in patients with Alzheimer’s-type cognitive impairment. During the last decades, science has demonstrated that life expectancy can be extended but this realization may not be as good as expected, for example, does it make sense to live longer if we are not able to even remember our name or recognize a close relative? The consequences of the current lifestyle, routine, long-term neurological effects from Covid-19, plus the lack of brain training, have turned neurodegenerative diseases into common diseases. As such, the main driver of our Company is to focus on a potential solution for these devastating diseases and the potential improvement of neuroplasticity. Anyone who has a relative with a neurodegenerative disease such as Alzheimer’s, would give everything to stop the invisible, slow and irreversible suffering that completely extinguishes the quality of life. The sublingual route of administration addresses many pharmaceutical and patient needs, highlighting convenient dosing for geriatric and psychiatric uncooperative patients with dysphagia (difficulty in swallowing). Sublingual administration presents several advantages over oral formulations such as quick absorption, predictable potency, reduced interaction with other medications and foods, and ease of administration. The sublingual tablets are being delivered to the site where we expect to commence the Phase II trial as soon as they arrived”, commented Alejandro Antalich, CEO of Biomind Labs.

“The main objective of developing this formulation was based on providing a scalable formulation that would be inexpensive, convenient for repeated and prolonged use, and pain-free. In the case of tryptamines, such as 5-MeO-DMT, it becomes neurochemically inactive when administered orally, since it is degraded by monoamine oxidase enzymes present in the gastrointestinal tract, preventing its absorption to the circulatory system and the central nervous system. For the oral route of administration, adding monoamine oxidase inhibitors to protect 5-MeO-DMT from the first pass-metabolism, becomes critical. This factor considerably increases the complexity of the formulation, which maximizes the achievement”, added Paola Díaz Dellavalle, PhD., Chief Scientific Officer of Biomind Labs.

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 the main psychedelic molecules, 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 Company’s statements regarding the Phase II trial of the Company’s novel drug candidate BMND08; the Company’s statements regarding its focus on a potential solution for these devastating diseases and the potential improvement of neuroplasticity; 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221228005258/en/

For more information, please contact:

Biomind Labs Inc.

Alejandro Antalich

Chief Executive Officer

Email: info@biomindlabs.com

Tel: + 598 97 702500

Source: Biomind Labs Inc.

FAQ

What is Biomind Labs' latest drug candidate BMND08?

BMND08 is a 5-MeO-DMT-based drug candidate aimed at treating depression and anxiety in Alzheimer's patients.

What advantages does the sublingual formulation provide?

The sublingual formulation offers quick absorption, convenient dosing, and is easier for patients with dysphagia.

When is Biomind Labs planning to begin the Phase II trial for BMND08?

Biomind Labs expects to commence the Phase II trial shortly after the delivery of the initial batch of sublingual tablets.

What are the potential challenges Biomind Labs faces with BMND08?

The main challenges include uncertainty in trial outcomes and potential regulatory hurdles.

What therapeutic conditions is BMND08 targeting?

BMND08 targets depression and anxiety related to Alzheimer's disease.