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BetterLife Obtains In Vivo PK Data for BETR-001 Confirming its Bioavailability in Brain

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BetterLife Pharma Inc. has announced positive pharmacokinetic data for its lead compound BETR-001 (2-bromo-LSD), confirming its bioavailability in the brain and plasma of treated mice. The study demonstrated that BETR-001 is non-hallucinogenic and achieves therapeutic levels, supporting its potential use in treating major depression and cluster headaches. Key findings include rapid appearance in plasma and brain within 10 minutes, sustained detection for up to 8 hours, and a half-life of approximately 1.5 hours. This data is crucial for BETR-001's IND application.

Positive
  • Positive in vivo pharmacokinetic data for BETR-001 supports its development.
  • Confirmed bioavailability in brain and plasma, indicating potential effectiveness.
  • Rapid absorption and sustained presence in critical tissues enhance therapeutic potential.
Negative
  • None.

VANCOUVER, British Columbia, March 16, 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 second generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has obtained the first set of positive in vivo pharmacokinetic (PK) data confirming the bioavailability of its lead compound BETR-001 (2-bromo-LSD, formerly TD-0148A) in the brain (target tissue) and plasma of treated mice. BETR-001 is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD). We had previously confirmed the non-hallucinogenic property of BETR-001 in the head-twitch-response (HTR) assay in mice, a model commonly used as a behavioral proxy in rodents for human hallucinogenic effects. A key objective of the current study was to confirm that lack of hallucinogenic property of BETR-001 is not due to its poor bioavailability especially in the target brain tissue.

The key PK data points from this mouse study conducted at Nucro-Technics (Scarborough, ON, Canada) include:

  • A bioanalytical method was established to measure 2-bromo-LSD in mouse plasma and brain tissues.
  • BETR-001 appeared quickly (10 minutes post dose) in the plasma and brain of mice following a single dose and remained detectable up to 8 hours post dose.
  • Plasma and brain exposure of BETR-001 increased in a time- and dose-dependent manner.
  • The mean terminal half-life of BETR-001 in plasma (~ 1.5 hours) was not significantly different among all dosing groups or between different sexes.

BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian, stated that “we are very pleased with the results from our preclinical animal study demonstrating a favorable PK profile of BETR-001 in support of our IND and future clinical programs in treatment of major depressive disorder and cluster headache patients. Although 2-bromo-LSD has been tested in rodents and human studies in the past, this is the first study to characterize the brain and plasma PK profile. These results provide strong evidence that BETR-001, manufactured by our patented synthesis and formulation process can reach the target organ (brain) and achieve the desired therapeutic range. These results will be part of BETR-001’s IND enabling non-clinical package that is currently under preparation.”

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. The global depression drugs market reached US$12.41 billion in 2019 and is projected to reach near US$25 billion by 2030. According to the WHO, depression is one of the leading causes of disability, impacting approximately 265 million people in the world.

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. The global benzodiazepines market is expected to grow to US$4.15 billion in 2017 (from US$3.48 billion in 2019) at a CAGR of 2.25%.

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 BetterLifePharma .

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 recent data did BetterLife Pharma release about BETR-001?

BetterLife Pharma announced positive pharmacokinetic data confirming the bioavailability of BETR-001 in the brain and plasma of mice.

What are the implications of the pharmacokinetic data for BETR-001?

The data supports BETR-001's therapeutic potential for conditions like major depressive disorder and cluster headaches.

How quickly does BETR-001 act in the body?

BETR-001 appeared in mouse plasma and brain within 10 minutes post-dose and remained detectable for up to 8 hours.

What is the significance of the half-life of BETR-001?

The mean terminal half-life of BETR-001 in plasma is approximately 1.5 hours, which is consistent across different dosing groups.

What is BETR-001's classification regarding its properties?

BETR-001 is a non-hallucinogenic derivative of LSD, offering potential treatment options without regulatory constraints.

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