Biomind Labs Announces Pre-IND Meeting Request Granted by FDA for Its New Chemical Entity Triptax™ Targeting Treatment-Resistant Depression

Rhea-AI Summary

Biomind Labs Inc. (OTC: BMNDF) announces the granting of a Pre-Investigational New Drug (Pre-IND) meeting by the FDA for their new chemical entity, Triptax™, aimed at treating Treatment-Resistant Depression. This meeting marks a significant step in advancing their clinical pipeline in the U.S. The company submitted a briefing package to the FDA and anticipates further guidance on their NCE development plan. CEO Alejandro Antalich emphasized the importance of this milestone, highlighting their focus on finalizing clinical data from their Phase II trial for their drug candidate BMND01.

Positive

• FDA granted Pre-IND meeting for Triptax™, a new chemical entity.
• Potential use of Triptax™ to treat Treatment-Resistant Depression.
• Advancement of clinical pipeline towards U.S. regulatory approval.

Negative

• None.

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 a Pre-Investigational New Drug (“Pre-IND”) meeting granted by the U.S. Food and Drug Administration (the “FDA”) for the Company’s new chemical entity (“NCE”) Triptax™.

“This is a new major step in our expansion to the U.S. to upgrade our clinical pipeline. Our NCE Triptax™ could be used as an active pharmaceutical ingredient or as a chemical precursor of Biomind’s novel formulations to treat depression, specifically Treatment-Resistant Depression, a Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat current depressive episodes,” commented Alejandro Antalich, CEO of Biomind Labs.

The Company has submitted a briefing package to the Division of Psychiatry, Center for Drug Evaluation and Research at the FDA, and awaits further feedback on the NCE Triptax™. The Pre-IND meeting is a critical step in the U.S. regulatory approval process that provides an opportunity for the Company and the FDA to discuss the NCE development plan and to obtain the FDA’s guidance for new clinical trials the Company may conduct on the NCE Triptax™.

“The meeting granted by the FDA comes at the right moment, as we are finalizing processing the clinical data from the first part of our Phase II trial of our novel drug candidate BMND01 for Treatment-Resistant Depression, a key element to support the design of our future investigational new drug clinical trials to be conducted in the U.S. Our main focus is to rapidly advance on our clinical pipeline to get the first registered pharmaceutical drug ready to be used by millions of patients across the world, while considering what is needed to secure the required funding to support large-scale clinical trials, such as democratic access, demonstrated efficacy, and safety and compliance with regulatory authorities,” concluded Alejandro Antalich, CEO 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, any timeframes and possible results associated with the Company’s potential expansion to the U.S. to upgrade its clinical pipeline; the potential uses of NCE Triptax™ and any claims of possible treatments associated with NCE Triptax™; any statements pertaining to the Company’s U.S. regulatory approval process and timelines associated therewith; the Company’s statements regarding the Phase II trial of the Company’s novel drug candidate BMND01; the Company’s future investigational new drug clinical trials to be conducted in the U.S.; the Company’s plans to rapidly advance on its clinical pipeline to get the first registered pharmaceutical drug ready to be used by millions of patients across the world; 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 FDA, 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/20221011006049/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 the significance of the FDA's Pre-IND meeting for Biomind Labs (BMNDF)?

The FDA's Pre-IND meeting is crucial for Biomind Labs as it allows discussion on the NCE Triptax™ development plan, which is necessary for future clinical trials.

How does Triptax™ aim to help patients with Treatment-Resistant Depression?

Triptax™ is intended to be an active pharmaceutical ingredient or a chemical precursor for formulations targeting Treatment-Resistant Depression.

What recent developments has Biomind Labs (BMNDF) announced regarding their clinical trials?

Biomind Labs is finalizing clinical data from their Phase II trial of drug candidate BMND01 and is planning new investigational trials based on FDA guidance.

How does Biomind Labs (BMNDF) plan to fund large-scale clinical trials?

Biomind Labs is focused on securing funding through various means, including demonstrating efficacy and safety to comply with regulatory requirements.

What are the main focuses of Biomind Labs (BMNDF) in their drug development?

The company is focused on developing novel formulations of psychedelic molecules for psychiatric disorders and ensuring their accessibility to patients.