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庐 (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 A尾 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 presenter脿 dati significativi su Leqembi庐 (lecanemab) al prossimo Alzheimer's Association International Conference (AAIC) che si terr脿 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 A尾.
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) anunci贸 que su socio Eisai presentar谩 datos importantes sobre Leqembi庐 (lecanemab) en la pr贸xima Conferencia Internacional de la Asociaci贸n de Alzheimer (AAIC) en Toronto, del 27 al 31 de julio de 2025.
Las presentaciones clave incluyen datos de eficacia y seguridad a cuatro a帽os del ensayo de extensi贸n abierta de la Fase 3 Clarity AD, nuevos datos sobre una formulaci贸n subcut谩nea para la dosificaci贸n de mantenimiento y estudios de casos del mundo real procedentes de entornos cl铆nicos en EE. UU. Adem谩s, se presentar谩n hallazgos de muestras de l铆quido cefalorraqu铆deo utilizando un novedoso inmunoensayo para medir protofibrillas de A尾.
Eisai lidera el desarrollo global y las presentaciones regulatorias de Leqembi, con Eisai y Biogen co-comercializando el producto. BioArctic mantiene los derechos de comercializaci贸n en la regi贸n n贸rdica en asociaci贸n con Eisai.
BioArctic AB (雮橃姢雼� 鞀ろ啞頇�毽�: BIOA B)電� 韺岉姼雱堨澑 Eisai臧� 2025雲� 7鞗� 27鞚茧秬韯� 31鞚缄箤歆� 韱犽韱犾棎靹� 鞐措Μ電� 鞎岇笭頃橃澊毹� 順戫殞 甑牅 頃欖垹雽�須�(AAIC)鞐愳劀 Leqembi庐 (lecanemab)鞐� 甏�頃� 欷戩殧頃� 靸堧鞖� 雿办澊韯半ゼ 氚滍憸頃� 鞓堨爼鞚措澕瓿� 氚濏様鞀惦媹雼�.
欤检殧 氚滍憸 雮挫毄鞐愲姅 3靸� Clarity AD 瓿店皽 霛茧波 鞐办灔 鞁滍棙鞚� 4雲勱皠鞚� 須姤 氚� 鞎堨爠靹� 雿办澊韯�, 鞙犾 韴棳毳� 鞙勴暅 頂柬晿 鞝滍槙鞐� 甏�頃� 靸堧鞖� 雿办澊韯�, 氙戈淡 鞛勳儊 頇橁步鞐愳劀鞚� 鞁れ牅 靷 鞐瓣惮臧� 韽暔霅╇媹雼�. 霕愴暅, A尾 頂勲韱犿敿敫岆Υ 旄§爼鞚� 鞙勴暅 靸堧鞖� 氅挫棴旄§爼氩曥潉 靷毄頃� 雵岇矙靾橃暋 靸橅攲 瓴瓣臣霃� 氚滍憸霅� 鞓堨爼鞛呺媹雼�.
Eisai電� Leqembi鞚� 鞝� 靹戈硠 臧滊皽 氚� 攴滌牅 鞝滌稖鞚� 欤茧弰頃橂┌, Eisai鞕� Biogen鞚� 瓿惦彊鞙茧 鞝滍拡鞚� 靸侅梾頇旐晿瓿� 鞛堨姷雼堧嫟. BioArctic鞚� Eisai鞕� 順戨牓頃橃棳 攵侅湢霟� 歆�鞐棎靹� 靸侅梾頇� 甓岆Μ毳� 氤挫湢頃橁碃 鞛堨姷雼堧嫟.
BioArctic AB (Nasdaq Stockholm : BIOA B) a annonc茅 que son partenaire Eisai pr茅sentera des donn茅es significatives sur Leqembi庐 (lecanemab) lors de la prochaine conf茅rence internationale de l'Alzheimer's Association (AAIC) 脿 Toronto, du 27 au 31 juillet 2025.
Les pr茅sentations cl茅s incluent des donn茅es d'efficacit茅 et de s茅curit茅 sur quatre ans issues de l'茅tude d'extension en ouvert de la Phase 3 Clarity AD, de nouvelles donn茅es sur une formulation sous-cutan茅e pour le traitement d'entretien, ainsi que des 茅tudes de cas en conditions r茅elles provenant de milieux cliniques am茅ricains. De plus, des r茅sultats obtenus 脿 partir d'茅chantillons de liquide c茅phalo-rachidien utilisant un nouvel immunodosage pour mesurer les protofibrilles d'A尾 seront pr茅sent茅s.
Eisai dirige le d茅veloppement mondial et les soumissions r茅glementaires pour Leqembi, avec une co-commercialisation du produit par Eisai et Biogen. BioArctic conserve les droits de commercialisation dans la r茅gion nordique en partenariat avec Eisai.
BioArctic AB (Nasdaq Stockholm: BIOA B) gab bekannt, dass sein Partner Eisai bedeutende neue Daten zu Leqembi庐 (Lecanemab) auf der bevorstehenden Alzheimer鈥檚 Association International Conference (AAIC) in Toronto vom 27. bis 31. Juli 2025 pr盲sentieren wird.
Zu den wichtigsten Pr盲sentationen geh枚ren vierj盲hrige Wirksamkeits- und Sicherheitsdaten aus der Phase-3-Clarity-AD-Open-Label-Verl盲ngerungsstudie, neue Daten zu einer subkutanen Formulierung f眉r die Erhaltungsdosierung sowie Fallstudien aus der klinischen Praxis in den USA. Au脽erdem werden Ergebnisse aus Liquorproben vorgestellt, die mit einem neuartigen Immunoassay zur Messung von A尾-Protofibrillen analysiert wurden.
Eisai leitet die globale Entwicklung und die Zulassung von Leqembi, wobei Eisai und Biogen das Produkt gemeinsam vermarkten. BioArctic beh盲lt 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庐) 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 A尾 protofibrils suggests continued refinement in monitoring treatment response. A尾 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 鈥� 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 鈥� 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.
- AG真人官方 world case studies:听A听Developing Topics Session on Sunday, July 27 (9:00 鈥� 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 鈥� 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 A尾 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:听
Oskar Bosson, VP Communications and Investor Relations
E-mail: [email protected]
Telephone: +46 704 107 180
About lecanemab (Leqembi庐)
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 (A尾).听
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,听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庐 (lecanemab) 鈥� 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鈩� 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听.听
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