BetterLife Obtains Positive In Vivo Oral Bioavailability, Food Effect and Pharmacokinetics Data for BETR-001

Rhea-AI Summary

BetterLife Pharma reported positive results from an oral bioavailability and food-effect pharmacokinetic study on BETR-001 (2-bromo-LSD) in beagle dogs. Key findings include:

• Oral bioavailability of BETR-001 was around 61% for fasted and 63% for fed states.
• No significant difference in bioavailability based on feeding status.
• The drug reached peak concentration at 0.5 hours and remained detectable for up to 8 hours.

These results support the therapeutic potential of BETR-001 and bolster plans for filing its IND application with the FDA, aiming to initiate human trials in H2 2022.

Positive

• Successful oral bioavailability study results for BETR-001, indicating therapeutic potential.
• Bioavailability rates of 61% and 63% demonstrate effective absorption regardless of food intake.
• Plans to file IND application with the FDA for human clinical trials in H2 2022.

Negative

• None.

VANCOUVER, British Columbia, Jan. 18, 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 2^nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has obtained positive results from an in vivo oral bioavailability and food-effect pharmacokinetic (PK) study on BETR-001 in beagle dogs. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD). Previous published studies have not included any data on PK for BETR-001. It was also unknown if presence of food would affect the bioavailability of orally administered BETR-001. The current study conducted by contract research organization, Nucro-Technics (Scarborough, ON, Canada), demonstrated the following key results after a single dose of oral BETR-001 (capsule) administered to beagle dogs:

• No significant difference was observed in bioavailability and total exposure of BETR-001 in PK profile of fed versus fasted beagle dogs.
• Oral bioavailability (%F), defined as the fraction of oral administered drug that reaches systemic circulation, was calculated to be 61% and 63% for fasted and fed states, respectively (no significant difference).
• The maximum systemic concentration (C_max) of BETR-001 after a single oral dose was reached at 0.5 hr (T_max), suggesting a quick uptake of the drug into the systemic circulation. The drug was detectable in systemic circulation eight hours post oral dose with an elimination rate constant (K_el) of 0.4 per hour, pointing to the fraction of drug eliminated per unit of time.
  

The findings demonstrate that oral administration of a single dose of BETR-001 can reach the therapeutic range in the systemic circulation. The PK elimination constant (K_el) of 0.4 per hour for BETR-001 indicates a low probability of toxicity as a result of drug accumulation in the systemic circulation.
“We are very pleased with the results of the first oral PK study for BETR-001 drug manufactured by BetterLife’s patented synthesis and formulation process. Although 2-bromo-LSD has been tested in rodents and human studies in the past, this is the first study to characterize its PK profile in vivo”, stated BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian. He added, “These data, together with the ongoing IND-enabling nonclinical toxicology studies, will support the filing of BETR-001’s IND application with the FDA and initiation of human clinical trials in H2 2022.”

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

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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 were the results of the recent study on BETR-001?

The study showed oral bioavailability of BETR-001 at 61% for fasted and 63% for fed conditions, with no significant differences based on food intake.

How does BETR-001 perform in bioavailability studies?

BETR-001 reached peak systemic concentration at 0.5 hours and was detectable for up to 8 hours post-administration.

What is the significance of the BETR-001 study findings?

The findings support BETR-001's potential therapeutic range and will aid in filing an IND application with the FDA.

When does BetterLife Pharma plan to initiate human trials for BETR-001?

Human clinical trials for BETR-001 are planned to begin in the second half of 2022.

What is the next step for BETR-001 after the study?

The next step is filing an IND application with the FDA to begin human clinical trials.