Lecanemab data presented at CTAD on early initiation and long-term treatment suggest increased patient benefit with maintained safety profile
BioArctic AB (NASDAQ Stockholm: BIOA B) partner Eisai presented three-year data for lecanemab (Leqembi®) at CTAD congress, showing increased benefits for early Alzheimer's patients. The drug demonstrated a 30% reduction in disease stage progression risk, with 46% of patients with low brain amyloid levels showing improved or maintained cognition after three years. The CDR-SB benefit expanded to -0.95 compared to ADNI-population at 36 months. Safety profile remained consistent, with most ARIA occurring in first six months. Data suggests continued treatment benefits even after plaque clearance, particularly in early-stage patients. In Great Britain's approved population, treatment showed 33% CDR-SB decline slowing versus 27% in total study population.
BioArctic AB (NASDAQ Stoccolma: BIOA B) e il partner Eisai hanno presentato dati triennali per lecanemab (Leqembi®) al congresso CTAD, mostrando benefici crescenti per i pazienti con Alzheimer in fase iniziale. Il farmaco ha dimostrato una riduzione del 30% del rischio di progressione della malattia, con il 46% dei pazienti con bassi livelli di amiloide cerebrale che mostrano un miglioramento o un mantenimento della cognizione dopo tre anni. Il beneficio del CDR-SB è aumentato a -0,95 rispetto alla popolazione ADNI a 36 mesi. Il profilo di sicurezza è rimasto coerente, con la maggior parte degli eventi avversi legati all’ARIA che si sono verificati nei primi sei mesi. I dati suggeriscono che i benefici del trattamento continuano anche dopo la rimozione delle placche, in particolare nei pazienti in fase iniziale. Nella popolazione approvata della Gran Bretagna, il trattamento ha mostrato un rallentamento del 33% nella diminuzione del CDR-SB rispetto al 27% nella popolazione totale dello studio.
BioArctic AB (NASDAQ Estocolmo: BIOA B) y su socio Eisai presentaron datos de tres años sobre lecanemab (Leqembi®) en el congreso CTAD, mostrando beneficios incrementales para los pacientes con Alzheimer en etapa temprana. El medicamento demostró una reducción del 30% en el riesgo de progresión de la etapa de la enfermedad, con un 46% de los pacientes con bajos niveles de amiloide cerebral mostrando mejoría o mantenimiento de la cognición después de tres años. El beneficio del CDR-SB se amplió a -0,95 en comparación con la población de ADNI a los 36 meses. El perfil de seguridad se mantuvo consistente, siendo la mayoría de los eventos ARIA ocurridos en los primeros seis meses. Los datos sugieren que los beneficios del tratamiento continúan incluso después de la eliminación de las placas, en particular en pacientes en etapa temprana. En la población aprobada de Gran Bretaña, el tratamiento mostró un descenso del 33% en la disminución del CDR-SB en comparación con el 27% en la población total del estudio.
BioArctic AB (NASDAQ 스톡홀름: BIOA B) 협력업체인 Eisai가 CTAD 학회에서 레카네맙 (Leqembi®)의 3년 데이터를 발표하였으며, 초기 알츠하이머 환자에 대한 이점이 증가하고 있음을 보여주었습니다. 이 약물은 질병의 진행 위험을 30% 감소시키는 것으로 나타났으며, 뇌 아밀로이드 수치가 낮은 환자 중 46%가 3년 후 인지 기능이 개선되거나 유지되었습니다. CDR-SB의 혜택은 36개월 시점에서 ADNI 집단과 비교하여 -0.95로 확대되었습니다. 안전성 프로필은 일관성을 유지하였으며, ARIA의 대부분은 첫 6개월 동안 발생하였습니다. 데이터에 따르면 플라크 제거 이후에도 초기 단계 환자에서 치료 혜택이 지속될 것으로 보입니다. 영국의 승인된 인구에서 치료는 전체 연구 인구에서 27%와 비교하여 CDR-SB 감소를 33%로 느리게 했습니다.
BioArctic AB (NASDAQ Stockholm: BIOA B) et son partenaire Eisai ont présenté des données sur trois ans concernant lecanemab (Leqembi®) lors du congrès CTAD, montrant des bénéfices accrus pour les patients atteints de la maladie d'Alzheimer à un stade précoce. Le médicament a montré une réduction de 30% du risque de progression du stade de la maladie, avec 46% des patients ayant des niveaux faibles d'amyloïde cérébrale montrant une amélioration ou un maintien de la cognition après trois ans. Le bénéfice du CDR-SB s'est étendu à -0,95 par rapport à la population ADNI à 36 mois. Le profil de sécurité est resté constant, la plupart des événements ARIA survenant au cours des six premiers mois. Les données suggèrent que les bénéfices du traitement se poursuivent même après l'élimination des plaques, en particulier chez les patients au stade précoce. Dans la population approuvée de Grande-Bretagne, le traitement a montré un déclin du CDR-SB de 33%, ralentissant par rapport à 27% dans l'ensemble de la population de l'étude.
BioArctic AB (NASDAQ Stockholm: BIOA B) und der Partner Eisai präsentierten auf dem CTAD-Kongress dreijährige Daten zu Lecanemab (Leqembi®), die zunehmende Vorteile für frühzeitige Alzheimer-Patienten zeigen. Das Medikament zeigte eine 30%ige Reduzierung des Fortschrittsrisikos der Erkrankung, wobei 46% der Patienten mit niedrigen Hirn-Amyloidwerten nach drei Jahren eine verbesserte oder erhaltene Kognition zeigten. Der Nutzen des CDR-SB erweiterte sich auf -0,95 im Vergleich zur ADNI-Population nach 36 Monaten. Das Sicherheitsprofil blieb konsistent, wobei die meisten ARIA-Ereignisse in den ersten sechs Monaten auftraten. Die Daten deuten darauf hin, dass die Behandlungsvorteile auch nach der Plaketenentfernung fortbestehen, insbesondere bei Patienten im frühen Stadium. In der genehmigten Bevölkerung Großbritanniens zeigte die Behandlung eine Verlangsamung des CDR-SB-Rückgangs um 33% im Vergleich zu 27% in der gesamten Studienpopulation.
- Treatment showed 30% reduction in disease stage progression risk
- 46% of low brain amyloid patients showed improved or maintained cognition after 3 years
- CDR-SB benefit expanded to -0.95 at 36 months vs ADNI-population
- 33% CDR-SB decline slowing in Great Britain's approved population vs 27% in total study
- No new safety concerns over three years of treatment
- ARIA side effects higher in ApoE4 homozygotes
- Disease continues to progress when treatment is stopped
Insights
The latest lecanemab data presents compelling evidence of sustained therapeutic benefits in early Alzheimer's treatment. The three-year follow-up data shows an impressive
The safety profile remains consistent with no new concerns over the extended treatment period. Notably, ARIA events predominantly occur within the first six months, with subsequent rates comparable to placebo. The data from British-approved populations (ApoE4 heterozygotes/non-carriers) shows enhanced efficacy with a
The completion of AHEAD 3-45 study enrollment and validation of plasma p-tau217 as a screening tool represents significant progress in early intervention strategies.
Highlights from the presentations at CTAD included:
Benefits of continued treatment with lecanemab for people with early Alzheimer's disease
Results from the open-label long-term extension study (OLE) following the core study of the lecanemab phase 3 Clarity AD study presented at AAIC in July, showed that the mean change from baseline in CDR-SB (global cognitive and functional scale) in the lecanemab treated group was -0.45 at 18 months compared to the placebo group. This had expanded to -0.95 compared to the ADNI-population at 36 months. The data also showed a
Clarity AD data presented at CTAD expanded on these initial results to include additional measurements resulting from three years of continuous lecanemab treatment in patients with low levels of amyloid accumulation in the brain at baseline (less than 60 centiloids). These data show that
Safety matters
No new safety findings were observed with continued lecanemab treatment over three years. Most Amyloid-related imaging abnormalities (ARIA) occurred in the first six months of treatment. After the first six months, ARIA rates were low and similar to ARIA rates on placebo. With regards to the incidence of ARIA by ApoE4 status during the continuous treatment, it was shown that the incidence was higher in ApoE4 homozygotes than in heterozygotes or non-carriers, but rates of new ARIA decreased after the completion of the 18 months core study as treatment continued, regardless of ApoE4 status.
Alzheimer's disease continues to progress when treatment is stopped – continued treatment even after plaque clearance beneficial for patients
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, potentially at a lower maintenance dose, which was shown to prevent reaccumulating of brain amyloid and worsening of plasma biomarkers.
Population approved for treatment in
In a presentation of the Clarity AD data focused on the Alzheimer's disease population approved for treatment in
Progress in the AHEAD 3-45 Study – patient enrollment completed
AHEAD 3-45 is a four-year phase 3 clinical study for individuals with preclinical AD, meaning they are clinically unimpaired but have intermediate or elevated levels of amyloid in their brains. Based on the amount of amyloid accumulation in the brain as determined by amyloid PET, subjects were assigned to two (2) trials with different dose settings: the A3 trial (approximately 400 people), for those with intermediate levels of amyloid in the brain, and the A45 trial (approximately 1000 people), for those with increased amyloid levels in the brain. Screening with blood biomarker tests was important to improve eligibility for amyloid PET testing and reduced screening failure on amyloid PET from more than
"The long-term data for lecanemab which our partner Eisai has presented are 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 data reported from clinical practice in the US and
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.
The information was released for public disclosure, through the agency of the contact person below, on October 31, 2024, at 08:30 a.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 (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 marketed in 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 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; matched ADNI participants show similar degree of decline to placebo group out to 18 months
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SOURCE BioArctic
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