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Anavex Life Sciences to Report New Long-Term Oral Blarcamesine Phase IIb/III Alzheimer’s Disease Data at J.P. Morgan 2025 Healthcare Conference

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Anavex Life Sciences (Nasdaq: AVXL) announced it will present new long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial for blarcamesine in early Alzheimer's disease at the J.P. Morgan 2025 Healthcare Conference. The presentation will showcase data from up to 144 weeks of continuous treatment in the OLE phase, following a 48-week double-blind study, totaling approximately 4 years of safety and efficacy data.

The oral once-daily treatment's scalable and easy-to-use features could potentially offer broader access to early Alzheimer's disease patients due to its convenient administration and favorable safety profile, addressing current healthcare ecosystem barriers.

Anavex Life Sciences (Nasdaq: AVXL) ha annunciato che presenterà nuovi dati a lungo termine del trial di Fase IIb/III ATTENTION-AD Open-Label-Extension (OLE) per blarcamesine nella malattia di Alzheimer precoce durante la Conferenza Sanitaria J.P. Morgan 2025. La presentazione mostrerà dati provenienti da un trattamento continuo di fino a 144 settimane nella fase OLE, dopo uno studio in doppio cieco di 48 settimane, totalizzando circa 4 anni di dati su sicurezza ed efficacia.

Le caratteristiche scalabili e facili da usare del trattamento orale da assumere una volta al giorno potrebbero offrire un accesso più ampio ai pazienti con Alzheimer precoce grazie alla sua somministrazione conveniente e al favorevole profilo di sicurezza, affrontando così gli attuali ostacoli nel sistema sanitario.

Anavex Life Sciences (Nasdaq: AVXL) anunció que presentará nuevos datos a largo plazo del ensayo de Fase IIb/III ATTENTION-AD Open-Label-Extension (OLE) para blarcamesine en la enfermedad de Alzheimer en etapas tempranas en la Conferencia de Salud J.P. Morgan 2025. La presentación mostrará datos de hasta 144 semanas de tratamiento continuo en la fase OLE, seguida de un estudio doble ciego de 48 semanas, totalizando aproximadamente 4 años de datos sobre seguridad y eficacia.

Las características escalables y de fácil uso del tratamiento oral de una vez al día podrían ofrecer un acceso más amplio a los pacientes con Alzheimer en etapas tempranas gracias a su administración conveniente y su perfil de seguridad favorable, abordando las barreras actuales en el ecosistema de atención médica.

Anavex Life Sciences (Nasdaq: AVXL)는 2025년 J.P. Morgan 헬스케어 컨퍼런스에서 조기 알츠하이머병에 대한 blarcamesine의 Phase IIb/III ATTENTION-AD 오픈 레이블 확장(OLE) 시험에서 새로운 장기 데이터를 발표할 것이라고 발표했습니다. 발표에서는 OLE 단계에서 최대 144주 동안 지속적인 치료에 대한 데이터가 제공되며, 48주 이중 맹검 연구 후 약 4년 동안의 안전성 및 유효성 데이터가 포함됩니다.

하루 한 번 복용하는 이 경구 치료는 사용이 간편하고 확장성이 뛰어나 조기 알츠하이머병 환자에게 폭넓은 접근을 제공할 수 있으며, 편리한 투여 방식과 유리한 안전성 프로파일로 현재의 의료 생태계 장벽을 해결할 수 있습니다.

Anavex Life Sciences (Nasdaq: AVXL) a annoncé qu'il présentera de nouvelles données à long terme provenant de l'essai ATTENTION-AD Open-Label-Extension (OLE) en phase IIb/III pour blarcamesine chez les patients atteints de la maladie d'Alzheimer précoce lors de la Conférence sur la Santé J.P. Morgan 2025. La présentation mettra en avant des données provenant d'un traitement continu allant jusqu'à 144 semaines dans la phase OLE, après une étude en double aveugle de 48 semaines, totalisant environ 4 ans de données sur la sécurité et l'efficacité.

Les caractéristiques évolutives et faciles à utiliser du traitement oral à prendre une fois par jour pourraient potentiellement offrir un accès plus large aux patients atteints de la maladie d'Alzheimer précoce grâce à son administration pratique et à son profil de sécurité favorable, s'attaquant ainsi aux barrières actuelles de l'écosystème de la santé.

Anavex Life Sciences (Nasdaq: AVXL) hat angekündigt, dass es auf der J.P. Morgan Healthcare Conference 2025 neue langfristige Daten aus der Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) Studie zu blarcamesine bei frühzeitiger Alzheimer-Krankheit präsentieren wird. Die Präsentation wird Daten aus bis zu 144 Wochen kontinuierlicher Behandlung in der OLE-Phase zeigen, nach einer 48-wöchigen doppelblinden Studie, die insgesamt circa 4 Jahre Sicherheits- und Wirksamkeitsdaten umfasst.

Die skalierbaren und einfach zu verwendenden Eigenschaften der einmal täglich einzunehmenden Behandlung könnten möglicherweise einen breiteren Zugang für Patienten mit frühzeitiger Alzheimer-Krankheit bieten, dank ihrer bequemen Anwendung und des günstigen Sicherheitsprofils, wodurch die aktuellen Barrieren im Gesundheitswesen überwunden werden.

Positive
  • Long-term safety and efficacy data spanning approximately 4 years will be presented
  • Oral administration format offers potential advantages for broader patient access
  • Favorable comparative safety profile reported
Negative
  • None.

Insights

The announcement of future data presentation at JPMorgan 2025 Healthcare Conference, while related to clinical trials, does not provide any actual results or data at this time. This is essentially a calendar announcement for a future event where data will be presented. Without the actual trial results or specific data points being shared, this news does not constitute immediately actionable or impactful information for investors. The mention of 144-week data and potential benefits remains speculative until the actual presentation occurs in January 2025.

Topline data from ATTENTION-AD Open-Label-Extension (OLE) 96/144-Week trial

J.P. Morgan 2025 Healthcare Conference, taking place January 13–16, 2025, in San Francisco, CA

NEW YORK, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced its upcoming presentation of topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13–16, 2025, in San Francisco, CA.

The presentation will highlight new findings from the ATTENTION-AD study evaluating potential benefit of oral once daily blarcamesine (ANAVEX®2-73) in early Alzheimer’s disease. The data reflect up to 144 weeks of continuous treatment in the OLE phase, following the prior 48-week double-blind Phase IIb/III study, for a total of up to 192 weeks (~4 years) of safety and efficacy data.

“These data showcase the breadth of our Alzheimer’s disease research and our ongoing commitment to scalable scientific innovation of longitudinal care,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We remain dedicated to advancing the field of research and treatment for this disease in order to better serve the millions of patients, families and providers in the Alzheimer’s community.”

The scalable and easy to use features of oral blarcamesine could make it an attractive option due to its convenient oral administration and favorable comparative safety profile. This could help overcome significant barriers in the currently complex healthcare ecosystem for Alzheimer's disease, potentially offering broader access to a diverse population with early 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 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


FAQ

What new data will Anavex Life Sciences (AVXL) present at JPM 2025 Healthcare Conference?

Anavex will present topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension trial, showing up to 144 weeks of continuous treatment results for blarcamesine in early Alzheimer's disease.

How long is the total treatment period in AVXL's ATTENTION-AD study?

The total treatment period is approximately 4 years (192 weeks), combining 144 weeks of the Open-Label-Extension phase with the prior 48-week double-blind Phase IIb/III study.

What are the key features of AVXL's blarcamesine for Alzheimer's treatment?

Blarcamesine is an oral once-daily treatment with scalable and easy-to-use features, offering convenient administration and a favorable comparative safety profile.

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