Anavex Life Sciences Announces Acceptance of Peer-Reviewed Manuscript of Oral Blarcamesine Phase IIb/III Data in a Reference Alzheimer’s Disease Journal
Anavex Life Sciences announced the acceptance of a peer-reviewed manuscript detailing Phase IIb/III trial results of oral blarcamesine for early Alzheimer's disease treatment. The manuscript, titled 'Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,' will be published in an Alzheimer's-focused medical journal around Q4 2024/Q1 2025. The company is proceeding with regulatory submission to the European Medicines Agency (EMA) in the current quarter of 2024.
Anavex Life Sciences ha annunciato l'accettazione di un manoscritto sottoposto a revisione paritaria che dettaglia i risultati del trial di fase IIb/III riguardanti il blarcamesine orale per il trattamento dell'Alzheimer precoce. Il manoscritto, intitolato 'Blarcamesine per il trattamento dell'Alzheimer precoce: Risultati dal trial ANAVEX2-73-AD-004 di fase IIB/III', sarà pubblicato in una rivista medica focalizzata sull'Alzheimer intorno al Q4 2024/Q1 2025. L'azienda sta procedendo con la domanda di registrazione all'Agenzia Europea dei Medicinali (EMA) nel corrente trimestre del 2024.
Anavex Life Sciences anunció la aceptación de un manuscrito revisado por pares que detalla los resultados del ensayo de fase IIb/III del blarcamesina oral para el tratamiento del Alzheimer temprano. El manuscrito, titulado 'Blarcamesina para el tratamiento del Alzheimer temprano: Resultados del ensayo ANAVEX2-73-AD-004 de fase IIB/III', será publicado en una revista médica enfocada en el Alzheimer alrededor de Q4 2024/Q1 2025. La compañía está avanzando con la presentación regulatoria a la Agencia Europea de Medicamentos (EMA) en el trimestre actual de 2024.
Anavex Life Sciences는 초기 알츠하이머병 치료를 위한 경구 blarcamesine의 2b/3상 시험 결과를 자세히 설명한 동료 심사 저널 원고의 수락을 발표했습니다. '초기 알츠하이머병 치료를 위한 Blarcamesine: ANAVEX2-73-AD-004 2B/3상 시험의 결과'라는 제목의 원고는 2024년 4분기/2025년 1분기경 알츠하이머 전문 의학 저널에 게재될 예정입니다. 이 회사는 2024년 현재 분기 동안 유럽 의약품청(EMA)에 규제 제출을 진행하고 있습니다.
Anavex Life Sciences a annoncé l'acceptation d'un manuscrit évalué par des pairs détaillant les résultats de l'essai de phase IIb/III du blarcamesine oral pour le traitement de la maladie d'Alzheimer précoce. Le manuscrit, intitulé 'Blarcamesine pour le traitement de la maladie d'Alzheimer précoce : Résultats de l'essai ANAVEX2-73-AD-004 de phase IIB/III', sera publié dans une revue médicale axée sur la maladie d'Alzheimer vers Q4 2024/Q1 2025. L'entreprise progresse avec la soumission réglementaire auprès de l'Agence européenne des médicaments (EMA) au cours du trimestre actuel de 2024.
Anavex Life Sciences gab die Annahme eines peer-reviewed Manuskripts bekannt, das die Ergebnisse der Phase IIb/III-Studie zu oralem blarcamesine zur Behandlung der frühen Alzheimer-Krankheit detailliert. Das Manuskript mit dem Titel 'Blarcamesine zur Behandlung der frühen Alzheimer-Krankheit: Ergebnisse aus der ANAVEX2-73-AD-004 Phase IIB/III-Studie' wird voraussichtlich in einem auf Alzheimer fokussierten medizinischen Journal im Zeitraum Q4 2024/Q1 2025 veröffentlicht. Das Unternehmen arbeitet derzeit an der regulatorischen Einreichung bei der Europäischen Arzneimittelagentur (EMA) im aktuellen Quartal 2024.
- Acceptance of Phase IIb/III trial results for publication in a peer-reviewed medical journal
- On track for EMA regulatory submission in Q4 2024
- None.
Insights
The acceptance of blarcamesine's Phase IIb/III trial manuscript for peer review represents a procedural milestone, but lacks substantial market-moving data. While the company frames this as progress toward their EMA submission in Q4 2024, the article provides no new clinical data, efficacy results, or safety information that would impact investment decisions. The publication timeline extending into Q1 2025 suggests a standard review process rather than expedited consideration.
The regulatory submission to EMA mentioned is more significant than the publication acceptance, but even this lacks concrete details about filing readiness or expected timeline for agency decisions. For a clinical-stage biotech with a
NEW YORK, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today announced the acceptance of a peer-reviewed manuscript titled, “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025.
“The publication in a peer-reviewed medical journal is an important milestone for the Anavex team and is a testament to the importance of the findings for the scientific and Alzheimer’s disease communities,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. “We are on track for regulatory submission of oral blarcamesine in Europe (EMA) in the current quarter 2024.”
“We are honored to be sharing this peer-reviewed manuscript in an international journal,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide and this forthcoming publication could be helpful to educate the medical and scientific community about the potential of oral blarcamesine for patients with Alzheimer's disease.”
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
About Alzheimer’s Disease
There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.1 The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's disease, at
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
2 Jönsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.
3 World Health Organization (WHO); 2021. Global status report on the public health response to dementia.
FAQ
When will Anavex's blarcamesine Phase IIb/III trial results be published?
What is the current regulatory status of AVXL's blarcamesine for Alzheimer's disease?
What phase trial results did AVXL get accepted for publication?
