BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder (MDD) Treatment With BETR-001

Rhea-AI Summary

BetterLife Pharma Inc. (CSE: BETR / OTCQB: BETRF) has received a favorable written response from the FDA regarding its pre-IND application for BETR-001, a non-hallucinogenic derivative of LSD aimed at treating major depressive disorder (MDD). The FDA's guidance supports BetterLife's program for BETR-001, enabling IND-enabling toxicology studies and clinical trial preparations. The Company plans to initiate human clinical trials for BETR-001 in the U.S. by Q3 2022, emphasizing its unique therapeutic potential for psychiatric disorders.

Positive

• Received FDA's favorable guidance for BETR-001's development.
• Plans to initiate human clinical trials by Q3 2022.
• BETR-001 is a non-hallucinogenic, unique molecule with therapeutic potential.

Negative

• None.

VANCOUVER, British Columbia, Jan. 20, 2022 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development and commercialization of 2nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has received a written response from the U.S. Food and Drug Administration (FDA) to its pre-investigational new drug (pre-IND) application for the treatment of MDD with BETR-001. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD) and is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials. The FDA response is in general agreement with the Company’s planned program for the development of BETR-001 and provided guidance regarding the BETR-001 IND-enabling non-clinical toxicology studies, its manufacturing strategy, and initial proposed clinical trial parameters.

“We are very pleased with the outcome of the BETR-001 pre-IND meeting with the FDA. The response from the FDA confirms that our current program will support the filing of BETR-001’s IND application and initiation of human clinical trials by the third quarter of this year. Being a non-hallucinogenic derivative of LSD makes BETR-001 a unique molecule with therapeutic potential for the treatment of debilitating psychiatric and neurological disorders with high unmet need, such as major depressive disorders and cluster headaches. Our team is fully dedicated to start the human clinical trials in the United States by early second half of this year,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

About BetterLife Pharma

BetterLife Pharma Inc. is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders.

BETR-001 (formerly TD-0148A), which is in preclinical and IND-enabling studies, is a non-hallucinogenic and non-controlled LSD derivative in development and it is unique in that it is unregulated and therefore can be self-administered. BetterLife’s synthesis patent for BETR-001 eliminates regulatory hurdles and its pending patent for composition and method of use covers treatment of depression, cluster headaches, post-traumatic stress disorder and other neuro-psychiatric and neurological disorders.

BETR-002 (formerly TD-010), which is in preclinical and IND-enabling studies, is based on honokiol, the active anxiolytic ingredient of magnolia bark. BetterLife’s pending method of use and formulations patent covers treatment of anxiety related disorders including benzodiazepine dependency.

BetterLife also owns a drug candidate for the treatment of viral infections such as COVID-19 and is in the process of seeking strategic alternatives for further development.

For further information, please visit BetterLife Pharma.

Contact Information

David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com
Phone: 1-778-887-1928

Cautionary Note Regarding Forward-Looking Statements

No securities exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

FAQ

What is BETR-001 and what is its significance?

BETR-001 is a non-hallucinogenic derivative of LSD developed by BetterLife Pharma for treating major depressive disorder (MDD), highlighting its unique therapeutic potential.

What was the FDA's response to BetterLife Pharma's pre-IND application?

The FDA provided guidance in agreement with BetterLife's development program for BETR-001, supporting its IND-enabling studies and clinical trial preparations.

When does BetterLife Pharma plan to start clinical trials for BETR-001?

BetterLife Pharma aims to begin human clinical trials for BETR-001 by the third quarter of 2022.

What are the potential benefits of BETR-001 for patients?

BETR-001 targets major depressive disorder and other psychiatric conditions, offering a non-hallucinogenic treatment option for patients with high unmet medical needs.