Lecanemab four-year efficacy and safety data to be presented at AAIC 2025
BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai will present significant new data on Leqembi® (lecanemab) at the upcoming Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31, 2025.
Key presentations include four-year efficacy and safety data from the Phase 3 Clarity AD Open-Label Extension trial, new data on a subcutaneous formulation for maintenance dosing, and real-world case studies from U.S. clinical settings. Additionally, findings from cerebrospinal fluid samples using a novel immunoassay for measuring Aβ protofibrils will be presented.
Eisai leads the global development and regulatory submissions for Leqembi, with both Eisai and Biogen co-commercializing the product. BioArctic maintains commercialization rights in the Nordic region in partnership with Eisai.
BioArctic AB (Nasdaq Stockholm: BIOA B) ha annunciato che il suo partner Eisai presenterà dati significativi su Leqembi® (lecanemab) al prossimo Alzheimer's Association International Conference (AAIC) che si terrà a Toronto dal 27 al 31 luglio 2025.
Le presentazioni principali includeranno i dati di efficacia e sicurezza a quattro anni dello studio di Fase 3 Clarity AD Open-Label Extension, nuovi dati su una formulazione sottocutanea per la terapia di mantenimento e studi di casi reali provenienti da contesti clinici negli Stati Uniti. Inoltre, saranno presentati risultati ottenuti da campioni di liquido cerebrospinale utilizzando un nuovo immunodosaggio per la misurazione dei protofibrilli di Aβ.
Eisai guida lo sviluppo globale e le procedure regolatorie per Leqembi, con Eisai e Biogen che co-commercializzano il prodotto. BioArctic mantiene i diritti di commercializzazione nella regione nordica in collaborazione con Eisai.
BioArctic AB (Nasdaq Estocolmo: BIOA B) anunció que su socio Eisai presentará datos importantes sobre Leqembi® (lecanemab) en la próxima Conferencia Internacional de la Asociación de Alzheimer (AAIC) en Toronto, del 27 al 31 de julio de 2025.
Las presentaciones clave incluyen datos de eficacia y seguridad a cuatro años del ensayo de extensión abierta de la Fase 3 Clarity AD, nuevos datos sobre una formulación subcutánea para la dosificación de mantenimiento y estudios de casos del mundo real procedentes de entornos clínicos en EE. UU. Además, se presentarán hallazgos de muestras de líquido cefalorraquídeo utilizando un novedoso inmunoensayo para medir protofibrillas de Aβ.
Eisai lidera el desarrollo global y las presentaciones regulatorias de Leqembi, con Eisai y Biogen co-comercializando el producto. BioArctic mantiene los derechos de comercialización en la región nórdica en asociación con Eisai.
BioArctic AB (나스닥 스톡홀름: BIOA B)는 파트너인 Eisai가 2025년 7월 27일부터 31일까지 토론토에서 열리는 알츠하이머 협회 국제 학술대회(AAIC)에서 Leqembi® (lecanemab)에 관한 중요한 새로운 데이터를 발표할 예정이라고 밝혔습니다.
주요 발표 내용에는 3상 Clarity AD 공개 라벨 연장 시험의 4년간의 효능 및 안전성 데이터, 유지 투여를 위한 피하 제형에 관한 새로운 데이터, 미국 임상 환경에서의 실제 사례 연구가 포함됩니다. 또한, Aβ 프로토피브릴 측정을 위한 새로운 면역측정법을 사용한 뇌척수액 샘플 결과도 발표될 예정입니다.
Eisai는 Leqembi의 전 세계 개발 및 규제 제출을 주도하며, Eisai와 Biogen이 공동으로 제품을 상업화하고 있습니다. BioArctic은 Eisai와 협력하여 북유럽 지역에서 상업화 권리를 보유하고 있습니다.
BioArctic AB (Nasdaq Stockholm : BIOA B) a annoncé que son partenaire Eisai présentera des données significatives sur Leqembi® (lecanemab) lors de la prochaine conférence internationale de l'Alzheimer's Association (AAIC) à Toronto, du 27 au 31 juillet 2025.
Les présentations clés incluent des données d'efficacité et de sécurité sur quatre ans issues de l'étude d'extension en ouvert de la Phase 3 Clarity AD, de nouvelles données sur une formulation sous-cutanée pour le traitement d'entretien, ainsi que des études de cas en conditions réelles provenant de milieux cliniques américains. De plus, des résultats obtenus à partir d'échantillons de liquide céphalo-rachidien utilisant un nouvel immunodosage pour mesurer les protofibrilles d'Aβ seront présentés.
Eisai dirige le développement mondial et les soumissions réglementaires pour Leqembi, avec une co-commercialisation du produit par Eisai et Biogen. BioArctic conserve les droits de commercialisation dans la région nordique en partenariat avec Eisai.
BioArctic AB (Nasdaq Stockholm: BIOA B) gab bekannt, dass sein Partner Eisai bedeutende neue Daten zu Leqembi® (Lecanemab) auf der bevorstehenden Alzheimer’s Association International Conference (AAIC) in Toronto vom 27. bis 31. Juli 2025 präsentieren wird.
Zu den wichtigsten Präsentationen gehören vierjährige Wirksamkeits- und Sicherheitsdaten aus der Phase-3-Clarity-AD-Open-Label-Verlängerungsstudie, neue Daten zu einer subkutanen Formulierung für die Erhaltungsdosierung sowie Fallstudien aus der klinischen Praxis in den USA. Außerdem werden Ergebnisse aus Liquorproben vorgestellt, die mit einem neuartigen Immunoassay zur Messung von Aβ-Protofibrillen analysiert wurden.
Eisai leitet die globale Entwicklung und die Zulassung von Leqembi, wobei Eisai und Biogen das Produkt gemeinsam vermarkten. BioArctic behält die Vermarktungsrechte in der nordischen Region in Partnerschaft mit Eisai.
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Insights
BioArctic's partner Eisai to present crucial 4-year lecanemab data and subcutaneous formulation findings at AAIC, potentially enhancing treatment's market position.
The upcoming presentation of four-year efficacy and safety data for lecanemab (Leqembi®) represents a significant milestone in Alzheimer's treatment evaluation. Long-term data is crucial for fully understanding a drug's sustained benefits and safety profile, particularly for chronic neurodegenerative conditions like Alzheimer's where treatment may continue for years.
The introduction of a subcutaneous formulation for maintenance dosing could substantially improve the treatment experience for patients. Current administration requires intravenous infusions, which necessitate clinical visits and medical supervision. A subcutaneous option would potentially allow for more convenient administration, possibly even home-based treatment, reducing healthcare utilization costs and improving patient adherence to therapy.
The presentation of real-world case studies from diverse U.S. clinical settings two years post-approval will provide valuable insights into how lecanemab performs outside the controlled environment of clinical trials. This data helps clinicians better understand practical implementation challenges and effectiveness across varied patient populations.
Additionally, the poster presentation on cerebrospinal fluid (CSF) samples using a novel immunoassay to measure Aβ protofibrils suggests continued refinement in monitoring treatment response. Aβ protofibrils are a key pathological target of lecanemab, and better measurement techniques could enhance personalization of treatment and provide earlier indicators of efficacy.
BioArctic's commercialization rights in the Nordic region, in partnership with Eisai, positions the company to benefit directly from lecanemab's continued clinical validation and potential market expansion through new formulations.
Key oral lecanemab presentations at AAIC
- Four-year data: On Wednesday, July 30, as part of the "Developing Topics Session: Innovative Therapeutic Approaches" (8:00 – 8:45 AM EDT), initial four-year findings will be presented on lecanemab from the Phase 3 Clarity AD Open-Label Extension in Early Alzheimer's Disease trial.
- Subcutaneous maintenance dosing: A Featured Research Session on Wednesday, July 30 (9:00 – 10:30 AM EDT) will include data on the potential of a new and convenient option for ongoing lecanemab treatment, the subcutaneous formulation for maintenance dosing.
- Real world case studies: A Developing Topics Session on Sunday, July 27 (9:00 – 10:30 AM EDT) will include data on real-world case studies and patient pathway learnings from diverse
U.S. clinical settings two years post-approval of lecanemab.
Key Lecanemab Poster Presentation at AAIC
- A Poster Presentation on Monday, July 28 (viewing available from 7:30 AM – 4:15 PM EDT) will share findings on cerebrospinal fluid (CSF) samples collected from the Clarity AD trial and analyzed using the novel, sensitive immunoassay developed to measure Aβ protofibrils in CSF.
Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.
The information was released for public disclosure, through the agency of the contact person below, on July 22, 2025, at 8:00 a.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and Investor Relations
E-mail: oskar.bosson@bioarctic.com
Telephone: +46 704 107 180
About lecanemab (Leqembi®)
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab is approved in the
Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap.
For further information, please visit www.bioarctic.com.
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