Biomind Labs Announces Completion of Dosing in Phase II Trial of Its DMT-Based Inhaled Formulation BMND01 for Treatment-Resistant Depression

Rhea-AI Summary

Biomind Labs has finalized the dose administration for 30 subjects in its Phase II trial of BMND01, aimed at treating Treatment-Resistant Depression. Results are expected in October 2022. This clinical trial explores an inhaled DMT formulation, intending to enhance rapid delivery into the bloodstream. Treatment-resistant depression affects 10-30% of patients, presenting significant healthcare challenges. Biomind Labs focuses on developing pharmaceutical formulations of psychedelics to offer modern treatments for various neurological and psychiatric conditions.

Positive

• Completion of dosing for 30 subjects in Phase II trial for BMND01.
• Anticipated results to be released in October 2022.
• First trial testing an inhaled formulation of DMT, which may enhance treatment delivery.

Negative

• Potential financing needs may impact operational continuity.
• Regulatory compliance challenges could affect business results.
• Adverse public perception of psychedelic treatments may hinder market acceptance.

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 the completion of dose administration of 30 healthy subjects in the Company’s Phase II trial of its novel drug candidate BMND01 for Treatment-Resistant Depression.

“The results of this first part of the world’s first clinical trial to test an inhaled formulation of DMT are expected to be ready in October 2022. The trial is designed with a fixed ascending two dose, concentration-response study, allowing DMT to be rapidly delivered directly into the systemic circulation in approximately 10 minutes, bypassing the first-pass metabolism, which is recognized as a major problem for some routes of DMT administration. The significant reduction in experience duration provides greater practical applicability to potentially deliver the psychedelic treatment in a supervised real-world clinical setting”, commented Alejandro Antalich, CEO of Biomind Labs.

Ten to thirty percent of people with depression exhibit treatment-resistant symptoms coupled with difficulties in social and occupational function, decline of physical health, poor quality of life, suicide ideation and attempts, self-injurious behavior, high relapse rate and increased health care utilization.¹ The objectives of the trial are to establish the safety and tolerability of DMT. In addition to evaluating side effects, this trial will also allow Biomind to explore the origin of the observed side effects, given that different associated physiological, behavioral, and cognitive markers will be collected before, during, and after the trial.

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, any timeframes and possible results associated with the Company’s clinical trial to test an inhaled formulation of DMT, any statements regarding the Company’s potential to deliver its novel drug candidate BMND01 in a supervised real-world clinical setting, 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 U.S. 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 “Treatment-resistant depression: therapeutic trends, challenges, and future directions” by Khalid Saad Al-Harbi, May 1, 2012.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220921005600/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' Phase II trial about?

The trial focuses on the safety and tolerability of BMND01, an inhaled DMT formulation for Treatment-Resistant Depression.

When will the results of the Phase II trial for BMND01 be available?

The results are expected in October 2022.

What is the significance of Treatment-Resistant Depression in the trial?

It affects 10-30% of patients, leading to severe health implications and a high rate of healthcare utilization.

What are the potential risks identified in Biomind Labs' trial?

Risks include the need for additional financing and regulatory compliance challenges.

What is DMT's role in Biomind Labs' research?

DMT is being studied for its potential as a rapid-acting treatment for psychiatric disorders, specifically in a novel inhaled form.