BetterLife Obtains Favourable Genotoxicity Data for Oral BETR-001
BetterLife Pharma has announced favorable results from IND-enabling genotoxicity studies for its lead drug candidate BETR-001, a non-hallucinogenic LSD derivative. The studies showed that oral BETR-001, even at high doses, demonstrates no bone marrow toxicity or DNA/chromosome damage. The GLP studies included bacterial reverse mutation assay and micronucleus tests both in vitro and in vivo. These safety assessments are required by the FDA for clinical trial approval. Additionally, the company issued 200,000 common shares and warrants following a $20,000 debenture conversion.
BetterLife Pharma ha annunciato risultati favorevoli dagli studi di genotossicità per l'abilitazione dell'IND per il suo principale candidato farmaco BETR-001, un derivato dell'LSD non allucinogeno. Gli studi hanno dimostrato che BETR-001, assunto per via orale anche a dosi elevate, non presenta tossicità sul midollo osseo né danni al DNA o ai cromosomi. Gli studi GLP hanno incluso il saggio di mutazione inversa batterica e test sui micronuclei, sia in vitro che in vivo. Queste valutazioni di sicurezza sono richieste dalla FDA per l'approvazione delle sperimentazioni cliniche. Inoltre, l'azienda ha emesso 200.000 azioni comuni e warrant dopo la conversione di un prestito obbligazionario di $20.000.
BetterLife Pharma ha anunciado resultados favorables de estudios de genotoxicidad para la habilitación del IND para su principal candidato a medicamento BETR-001, un derivado de LSD no alucinógeno. Los estudios mostraron que BETR-001, administrado por vía oral, incluso a dosis altas, no presenta toxicidad en la médula ósea ni daño en el ADN/cromosomas. Los estudios GLP incluyeron el ensayo de mutación reversa bacteriana y pruebas de micronúcleos, tanto in vitro como in vivo. Estas evaluaciones de seguridad son requeridas por la FDA para la aprobación de ensayos clínicos. Además, la compañía emitió 200,000 acciones comunes y warrant luego de la conversión de un debentur de $20,000.
BetterLife Pharma는 주요 약물 후보인 BETR-001의 IND 승인 가능성에 대한 유전독성 연구에서 긍정적인 결과를 발표했습니다. BETR-001은 환각 작용이 없는 LSD 유도체입니다. 연구 결과, 구강 복용한 BETR-001은 고용량에서도 골수 독성이나 DNA/염색체 손상을 나타내지 않았습니다. GLP 연구는 세균 역변이 검사와 미세핵 검사를 포함했으며, 모두 체외 및 체내에서 수행되었습니다. 이러한 안전성 평가들은 FDA의 임상 시험 승인을 위해 요구됩니다. 또한, 회사는 20,000달러의 전환사채 발행 후 200,000주 일반주식과 권리를 발행했습니다.
BetterLife Pharma a annoncé des résultats favorables d'études de génotoxicité permettant l'IND pour son principal candidat médicament BETR-001, un dérivé de LSD non hallucinogène. Les études ont montré que BETR-001, administré par voie orale même à fortes doses, ne présente aucune toxicité médullaire ni dommage à l'ADN/aux chromosomes. Les études GLP comprenaient des essais de mutation inverse bactérienne et des tests de micronoyaux, in vitro et in vivo. Ces évaluations de sécurité sont requises par la FDA pour l'approbation des essais cliniques. De plus, la société a émis 200 000 actions ordinaires et warrants suite à une conversion de débenture de 20 000 $.
BetterLife Pharma hat günstige Ergebnisse aus IND-erlaubten Genotoxizitätsstudien für seinen Hauptkandidaten BETR-001, ein nicht halluzinogener LSD-Derivat, bekannt gegeben. Die Studien zeigten, dass BETR-001, auch bei hohen Dosen, keine Knochenmarktoxizität oder DNA/Cromosom-Schäden aufweist. Die GLP-Studien umfassten den bakteriellen Rückmutationstest und Mikronukleustests sowohl in vitro als auch in vivo. Diese Sicherheitsbewertungen sind von der FDA für die Genehmigung klinischer Studien erforderlich. Darüber hinaus hat das Unternehmen 200.000 Stammaktien und Optionen nach der Umwandlung einer Anleihe von 20.000 USD ausgegeben.
- Successful completion of FDA-required genotoxicity studies showing no toxicity
- BETR-001 demonstrated safety even at high doses
- Progress toward IND-enabling studies completion and clinical trials
- Dilution of shareholder value through issuance of new shares and warrants
VANCOUVER, British Columbia, Oct. 23, 2024 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic derivative of lysergic acid diethylamide (“LSD”), announced it has completed one of its IND-enabling genotoxicity studies of BETR-001. The studies demonstrated that oral BETR-001, even at very high doses, does not show any evidence of bone marrow toxicity or mutagenic (DNA mutation) and clastogenic (chromosome damage) activities.
The GLP genotoxicity studies conducted on BETR-001 included in vitro bacterial reverse mutation assay, in vitro micronucleus test, and in vivo micronucleus test in male and female rats. These studies are a critical component of the safety assessment required by the U.S. Food and Drug Administration (FDA) and needed for entry into clinical trials.
Dr. Ahmad Doroudian, CEO of BetterLife, commented, “We are very excited about these safety data that demonstrate the lack of genetic risk for our lead drug candidate. BETR-001 is a unique non-hallucinogenic derivative of LSD with robust activity in animal depression and anxiety models without the burden of being hallucinogenic. The clean genotoxicity profile of BETR-001 gets us one step closer to completing our full IND-enabling studies and starting our clinical trials, as soon as the studies conclude.”
The Company also announces that it has issued 200,000 common shares and 200,000 share purchase warrants pursuant to the conversion of convertible debentures totalling
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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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.
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