Long-term lecanemab data show increased patient benefit with maintained safety profile
BioArctic AB's partner Eisai presented three-year data for lecanemab (Leqembi®) at the Alzheimer's Association International Conference 2024. Key findings include:
1. Increased patient benefit: Lecanemab reduced clinical decline by -0.95 on the CDR-SB scale after three years, up from -0.45 at 18 months.
2. Maintained safety profile: No new safety concerns observed over three years.
3. Early-stage patient improvement: 51% of patients with no or low tau showed improvement after three years.
4. Continued biomarker impact: Lecanemab positively affects biomarkers throughout treatment.
5. Tau spread reduction: Treatment slowed tau accumulation across brain regions.
These results suggest lecanemab's potential as a disease-modifying treatment for early Alzheimer's disease, with increasing benefits over time.
Il partner di BioArctic AB, Eisai, ha presentato i dati triennali per lecanemab (Leqembi®) durante la Conferenza Internazionale dell'Alzheimer Association 2024. I risultati chiave includono:
1. Aumento del beneficio per i pazienti: Lecanemab ha ridotto il declino clinico di -0,95 sulla scala CDR-SB dopo tre anni, rispetto a -0,45 a 18 mesi.
2. Profilo di sicurezza mantenuto: Non sono stati osservati nuovi problemi di sicurezza nel corso di tre anni.
3. Miglioramento nei pazienti in fase iniziale: Il 51% dei pazienti con tau assente o basso ha mostrato miglioramenti dopo tre anni.
4. Impatto continuo sui biomarcatori: Lecanemab influisce positivamente sui biomarcatori durante tutto il trattamento.
5. Riduzione della diffusione del tau: Il trattamento ha rallentato l'accumulo di tau in diverse regioni del cervello.
Questi risultati suggeriscono il potenziale di lecanemab come trattamento modificante la malattia per l'Alzheimer precoce, con benefici crescenti nel tempo.
El socio de BioArctic AB, Eisai, presentó datos a tres años para lecanemab (Leqembi®) en la Conferencia Internacional de la Asociación de Alzheimer 2024. Las conclusiones clave incluyen:
1. Aumento del beneficio para los pacientes: Lecanemab redujo el declive clínico en -0,95 en la escala CDR-SB después de tres años, subiendo de -0,45 a 18 meses.
2. Perfil de seguridad mantenido: No se observaron nuevas preocupaciones de seguridad durante tres años.
3. Mejora en pacientes en etapa temprana: El 51% de los pacientes con tau ausente o bajo mostró mejoría después de tres años.
4. Impacto continuo en biomarcadores: Lecanemab afecta positivamente a los biomarcadores a lo largo del tratamiento.
5. Reducción de la propagación del tau: El tratamiento ralentizó la acumulación de tau en diversas regiones del cerebro.
Estos resultados sugieren el potencial de lecanemab como un tratamiento modificador de la enfermedad para la enfermedad de Alzheimer en etapa temprana, con beneficios crecientes con el tiempo.
BioArctic AB의 파트너 Eisai는 2024년 알츠하이머 협회 국제 회의에서 레카네맙 (Leqembi®)에 대한 3년 데이터를 발표했습니다. 주요 발견 사항은 다음과 같습니다:
1. 환자 혜택 증가: 레카네맙은 3년 후 CDR-SB 척도에서 -0.95의 임상적 감소를 나타내었으며, 이는 18개월의 -0.45에서 증가한 수치입니다.
2. 안전성 프로필 유지: 3년 동안 새로운 안전 문제는 관찰되지 않았습니다.
3. 초기 단계 환자 개선: 타우가 없거나 낮은 51%의 환자가 3년 후 개선을 보였습니다.
4. 지속적인 바이오마커 영향: 치료 전반에 걸쳐 레카네맙이 바이오마커에 긍정적인 영향을 미쳤습니다.
5. 타우 전파 감소: 치료가 여러 뇌 영역에서 타우 축적을 늦추었습니다.
이 결과들은 레카네맙이 초기 알츠하이머병에 대한 질병 수정 치료제로서의 잠재력을 가지고 있으며 시간이 지남에 따라 증가하는 혜택을 나타냅니다.
Le partenaire de BioArctic AB, Eisai, a présenté des données sur trois ans concernant lecanemab (Leqembi®) lors de la Conférence internationale de l'Association Alzheimer 2024. Les résultats clés incluent :
1. Bénéfice accru pour les patients : Lecanemab a réduit le déclin clinique de -0,95 sur l'échelle CDR-SB après trois ans, contre -0,45 à 18 mois.
2. Profil de sécurité maintenu : Aucune nouvelle préoccupation de sécurité observée au cours de ces trois années.
3. Amélioration des patients en phase précoce : 51 % des patients sans ou avec peu de tau ont montré une amélioration après trois ans.
4. Impact continu sur les biomarqueurs : Lecanemab affecte positivement les biomarqueurs tout au long du traitement.
5. Réduction de la propagation du tau : Le traitement a ralenti l'accumulation de tau à travers les régions cérébrales.
Ces résultats suggèrent le potentiel de lecanemab en tant que traitement modificateur de la maladie pour la maladie d'Alzheimer précoce, avec des bénéfices croissants au fil du temps.
Der Partner von BioArctic AB, Eisai, präsentierte auf der Alzheimer Association International Conference 2024 die Daten der dreijährigen Studie zu Lecanemab (Leqembi®). Wichtige Erkenntnisse sind:
1. Erhöhter Patienten Nutzen: Lecanemab reduzierte den klinischen Abbau um -0,95 auf der CDR-SB-Skala nach drei Jahren, gegenüber -0,45 nach 18 Monaten.
2. Beibehaltung des Sicherheitsprofils: Keine neuen Sicherheitsbedenken wurden über drei Jahre hinweg festgestellt.
3. Verbesserung bei Patienten im frühen Stadium: 51% der Patienten ohne oder mit niedrigem Tau zeigten nach drei Jahren Verbesserungen.
4. Fortlaufende biomarker BEWÄHRUNG: Lecanemab hat während der gesamten Behandlung positive Auswirkungen auf Biomarker.
5. Reduzierung der Tau-Ausbreitung: Die Behandlung verlangsamte die Tau-Akkumulation in verschiedenen Gehirnregionen.
Diese Ergebnisse deuten darauf hin, dass Lecanemab das Potenzial hat, eine krankheitsmodifizierende Therapie für frühe Alzheimer-Erkrankungen zu sein, mit zunehmenden Vorteilen im Laufe der Zeit.
- Lecanemab showed increased patient benefit after three years, reducing clinical decline by -0.95 on the CDR-SB scale
- 51% of early-stage Alzheimer's patients (with no or low tau) showed improvement after three years of treatment
- Lecanemab maintained its safety profile over three years with no new safety concerns
- Treatment slowed tau accumulation across brain regions, indicating potential disease-modifying effects
- Lecanemab continues to positively impact biomarkers throughout the course of treatment
- Alzheimer's disease continues to progress when treatment is stopped, even after plaque clearance
Insights
The long-term data for lecanemab in Alzheimer's disease treatment is highly significant. The three-year results demonstrate a sustained and increasing benefit for patients with early Alzheimer's, with a reduction in clinical decline of
Particularly noteworthy is the data from the earliest patient cohort, where
The safety profile remains consistent with previous findings, with most ARIA events occurring in the first six months and no new safety concerns emerging over the three-year period. This is important for long-term treatment viability.
The tau PET substudy results are especially intriguing, showing that lecanemab slows tau accumulation across brain regions. This, coupled with improvements in CSF MTBR-tau243 and p-tau217, suggests a potential disease-modifying effect on tau pathophysiology, which is a key factor in Alzheimer's progression.
These findings collectively strengthen the case for lecanemab as a promising long-term treatment option for early Alzheimer's disease, potentially offering sustained benefits and altering the disease course when initiated early.
The long-term data presented for lecanemab has significant positive implications for BioArctic AB and its partner Eisai. The sustained and increasing patient benefit over three years, coupled with a maintained safety profile, strengthens lecanemab's market position in the competitive Alzheimer's treatment landscape.
Key financial considerations include:
- Market potential: The data suggesting
51% of early-stage patients showed improvement after three years could drive increased adoption and potentially expand the eligible patient population. - Competitive advantage: The long-term efficacy and safety data may differentiate lecanemab from competitors, potentially leading to increased market share and pricing power.
- Revenue streams: BioArctic's right to commercialize lecanemab in the Nordic region, coupled with the joint commercialization plans with Eisai in Europe, presents significant revenue opportunities.
- R&D investment validation: These results validate BioArctic's research approach and collaboration model, potentially attracting more partnerships and investment in their pipeline.
While specific financial projections would require more detailed market analysis, these results are likely to positively impact BioArctic's stock valuation. Investors should monitor upcoming regulatory decisions, particularly in Europe and the execution of commercialization strategies in the Nordic region.
The presentations from AAIC will be available on the Eisai Co. Ltd. investor page by 01:00 a.m. on July 31st CET.
Highlights of the presentations included:
- Clear and meaningful long-term treatment effect – Three years of continuous lecanemab treatment reduced clinical decline by -0.95 as measured by the cognitive and functional scale CDR-SB, compared to ADNI[1] data. A clear increase compared to the effect of -0,45 at 18 months. This shows continued clinically and personally meaningful benefit for early AD patients.[2]
- Safety matters – No new safety findings have been observed with continued lecanemab treatment over three years. Most ARIA occurred in the first six months of treatment. After the first six months, ARIA rates are low and similar to ARIA rates on placebo. Most patients who had ARIA had CDR-SB assessments after the event. Sensitivity analyses showed ARIA had no impact on cognition or function. From these results ARIA was not associated with accelerated long-term progression.[2]
- More than
50% of patients in the earliest stage of AD continued to show improvement after three years of lecanemab treatment – The Clarity AD study included an optional tau PET substudy which included patients with no tau or a low accumulation of tau in the brain. As tau begins to accumulate in the brain, cognition and function start to decline; therefore, patients with no tau or low tau in the brain represent an early stage of AD. After three years of lecanemab treatment,59% of these patients (24/41) showed improvement or no decline, and51% (21/41) showed improvement from baseline on the CDR-SB. This suggests that earlier initiation of treatment with lecanemab may have a significant positive impact on disease progression and may provide continued benefits to patients with early AD over the long-term.[2]
- Even after plaque clearance, AD continues to progress when treatment is stopped. Lecanemab continues to positively impact biomarkers over the course of treatment – Clinical data and biomarkers such as Aβ42/40 ratio, pTau181, pTau217 and GFAP suggests that AD does not stop progressing after plaque clearance. Data indicates that patients continue to benefit by remaining on treatment as lecanemab maintains improvement in the fluid biomarkers of amyloid pathophysiology.[2]
- Lecanemab slows tau spread across brain regions – In the tau PET substudy, continuous lecanemab treatment slowed the rate of increase in tau accumulation across the brain regions measured by tau PET. CSF MTBR-tau243 has high correlation with tau PET and increases with the progression of AD pathology. Treatment with lecanemab slows the increase in CSF MTBR-tau243. Additionally, lecanemab improved p-tau217 and other biomarkers related to neuroinflammation and neurodegeneration. This indicates a potential disease-modifying effect of lecanemab on tau pathophysiology.[2],[3]
"Long-term data for lecanemab which our partner Eisai has presented today are very impressive. It shows that the patient benefit of lecanemab continues to increase over time, which is exactly what is expected from a disease modifying treatment. In addition, the safety profile continues to be in line with what we saw in the phase three study," said Gunilla Osswald, CEO at BioArctic. "It is also encouraging to see the result from the very earliest cohort of patients, where over 50 percent showed improvement over 36 months."
Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on July 30, 2024, at 11:00 p.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
About lecanemab (generic name, brand name: 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
Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.
Eisai has also submitted applications for approval of lecanemab in 12 other countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the
Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between 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 under certain conditions 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.
[1] ADNI (Alzheimer's Disease Neuroimaging Initiative) is a clinical research project launched in 2005 to develop methods to predict the onset of AD and to confirm the effectiveness of treatments. The ADNI observational cohort represents the exact population of those in Clarity AD study was pre-selected prior to the start of Clarity AD. Matched ADNI participants show similar degree of decline to placebo group out to 18 months.
[2] Sperling, R., Selkoe, D., Reyderman, L., Youfang, C., Van Dyck, C. (2024, July 28 - August 1). Does the Current Evidence Base Support Lecanemab Continued Dosing for Early Alzheimer's Disease? [Perspectives Session] Alzheimer's Association International Conference,
[3] Willis, B., Charil, A., Fox, N., Teunissen, C. (2024, July 28-August 1). Beyond Amyloid Removal with Lecanemab Treatment: Update on Long-Term Fluid Biomarkers. [Featured Research Session] Alzheimer's Association International Conference,
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FAQ
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