BetterLife Advances BETR-001 IND-enabling Studies
BetterLife Pharma Inc. announces progress in its IND-enabling studies for BETR-001, a non-hallucinogenic LSD derivative for mental disorders. The company has initiated GLP studies for metabolism and genotoxicity. BETR-001 has shown robust activity in animal models without hallucinogenic effects. BetterLife plans to file the IND application with the FDA by the end of 2024.
In March 2024, BetterLife disclosed its intention to conduct private placement offerings of Convertible Debentures to fund the development of BETR-001. The company closed a tranche of $30,000 10% Convertible Debentures with a two-year maturity to further advance BETR-001 development. Each Convertible Debenture is convertible into units of the company, including one common share and one share purchase warrant.
BETR-001 has shown robust activity in animal depression and anxiety models without hallucinogenic effects, indicating potential therapeutic benefits for mental disorders.
Initiation of IND-enabling studies for metabolism and genotoxicity demonstrates BetterLife's commitment to moving forward with the development of BETR-001.
Completion of the GLP toxicology study showing BETR-001's high tolerability even at high doses is a promising indicator for its safety profile.
Planning to file the BETR-001 IND application by the end of 2024 reflects BetterLife's progress towards advancing the therapeutic candidate for clinical trials.
The successful closure of the tranche of Convertible Debentures provides BetterLife with additional funding to support the development of BETR-001.
The need for further private placement offerings of Convertible Debentures implies a continuous reliance on external funding sources, potentially leading to dilution of existing shareholders' stakes.
Completion of the IND application and subsequent initiation of human clinical trials are subject to regulatory approval and may face delays or challenges, impacting the timeline for BETR-001's development.
VANCOUVER, British Columbia, May 01, 2024 (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 non-hallucinogenic LSD-based therapeutics for mental disorders, announces that it has advanced in its IND-enabling studies for BETR-001, a non-hallucinogenic derivative of LSD (lysergic acid diethylamide). The IND-enabling metabolism and genotoxicity GLP studies have been initiated.
Dr. Ahmad Doroudian, CEO of BetterLife, commented, “BETR-001 is a unique non-hallucinogenic derivative of LSD, which we have shown has robust activity in animal depression and anxiety models without the burden of being hallucinogenic. We have completed the first set of GLP toxicology study of oral BETR-001 in animals which shows that BETR-001, even with repeat dosing at high doses, is very well tolerated. We are now initiating the other IND-enabling nonclinical toxicology studies that will support the filing of BETR-001’s IND application with the FDA and initiation of human clinical trials.”
BetterLife has had its BETR-001 pre-IND meeting with the FDA, and projects to file the BETR-001 IND by end of 2024.
BetterLife announced in March 2024 that it intended to complete further private placement offerings (the “Private Placements”) of convertible debentures (“Convertible Debentures”). The Company also closed a tranche of
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, 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 major depressive disorder, anxiety disorder and neuropathic pain and other neuro-psychiatric and neurological disorders.
BETR-002, 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 and is in the process of seeking strategic alternatives for further development.
For further information, please visit BetterLife Pharma.
Contact
David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com
Phone: 1-778-887-1928
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