Long-term lecanemab data confirm enhanced patient benefit with sustained safety
STOCKHOLM, July 30, 2024 – BioArctic AB's (Nasdaq Stockholm: BIOA B) partner Eisai has unveiled promising new data on lecanemab (brand name: Leqembi®), showing sustained benefits for patients with early Alzheimer's disease over a three-year period. Presented at the Alzheimer's Association International Conference (AAIC) 2024 in Philadelphia and virtually, the findings highlight lecanemab's continued effectiveness in improving cognitive and functional scores while maintaining a stable safety profile.
Key insights from the conference include:
Sustained Treatment Benefits
Lecanemab has demonstrated a significant long-term impact on reducing clinical decline. Over three years, patients on continuous lecanemab treatment experienced a reduction in clinical decline by -0.95 on the cognitive and functional scale CDR-SB, compared to ADNI data. This is an improvement from the -0.45 effect observed at 18 months, indicating that early Alzheimer's disease patients derive continued and meaningful benefits from extended lecanemab treatment.
Safety Profile
The safety profile of lecanemab remains consistent over three years, with no new safety concerns reported. Most ARIA (amyloid-related imaging abnormalities) incidents occurred within the first six months and were comparable to rates observed in placebo groups thereafter. Sensitivity analyses confirmed that ARIA did not adversely affect cognition or function, and it was not linked to accelerated disease progression.
Early Stage Improvements
Data from the Clarity AD study, which included an optional tau PET substudy, revealed that more than half of the patients in the earliest stages of Alzheimer's disease showed cognitive and functional improvements after three years of treatment with lecanemab. Specifically, 59% of these patients exhibited either improvement or no decline, and 51% showed improvement from baseline on the CDR-SB scale. This underscores the potential benefits of initiating lecanemab treatment at the earliest stages of the disease.
Biomarkers and Disease Progression
Clinical data indicate that Alzheimer's disease continues to progress even after plaque clearance. However, ongoing lecanemab treatment positively influences biomarkers associated with amyloid pathology, such as the Aβ42/40 ratio, pTau181, pTau217, and GFAP. These biomarkers suggest that continuous treatment helps maintain improvements and provides ongoing patient benefits.
Tau Pathophysiology
Another significant finding is that lecanemab slows the spread of tau proteins across brain regions, as observed in the tau PET substudy. Continuous treatment reduced the rate of tau accumulation, and high correlations were noted between CSF MTBR-tau243 levels and the progression of Alzheimer's pathology. Lecanemab also improved other biomarkers related to neuroinflammation and neurodegeneration, indicating a potential disease-modifying effect on tau pathophysiology.
Gunilla Osswald, CEO of BioArctic, commented on the findings: "The long-term data for lecanemab presented by our partner Eisai are very impressive. It shows that patient benefits continue to increase over time, which is exactly what is expected from a disease-modifying treatment. Additionally, the safety profile remains consistent with what we observed in the Phase 3 study. It is also encouraging to see that over 50 percent of the earliest cohort of patients showed improvement over 36 months."
Lecanemab is the result of a collaborative effort between BioArctic and Eisai, originating from the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development and global commercialization of lecanemab, while BioArctic retains commercialization rights in the Nordic region. The companies are preparing for joint commercialization in the region, pending European regulatory approval.
This data reinforces the potential of lecanemab as a long-term treatment option for early Alzheimer's disease, offering sustained cognitive and functional improvements with a consistent safety profile.
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