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New Insights into Lecanemab's Efficacy at AAIC 2025

BioArctic AB, a prominent name in innovative biomedical research, joined forces with Eisai to present the latest findings on lecanemab (Leqembi®) during the 2025 Alzheimer’s Association International Conference (AAIC) held in Toronto from July 27 to 31. This year's conference highlighted significant advancements in Alzheimer’s treatment, particularly focusing on lecanemab's long-term effects and its safety profile.

Long-term Clinical Benefits of Lecanemab

The four-year treatment data from the phase 3 Clarity AD open-label extension study introduced compelling evidence about lecanemab's efficacy. The study revealed that lecanemab significantly delayed the progression of early Alzheimer's disease (AD), providing a critical therapeutic window for patients. Specifically, over the course of the study, lecanemab-treated patients exhibited much slower clinical decline compared to their counterparts receiving a placebo. The statistical change from the baseline after 18 months indicated a 27% reduction in decline, effectively slowing disease progression by nearly one year based on assessment metrics.

Among patients who completed the core study, an astonishing 95% opted to continue in the open-label extension, illustrating high engagement and hope for sustained improvement. Over three years, lecanemab showcased a 1.01-point decrease in decline when benchmarked against prevalent Alzheimer’s cohorts, and this number rose to a notable 1.75 points after four years.

The study also segmented participants based on tau levels, a biomarker indicative of disease severity. Encouragingly, 69% of participants with low tau levels demonstrated either stability or improvement after four years of lecanemab treatment, with significant enhancements in cognitive function measured by various cognitive scales, demonstrating the potential of early intervention.

Real-world Effectiveness of Lecanemab

Adding to the body of evidence, interim results from a multicenter real-world study conducted in the U.S. indicated robust performance of lecanemab outside clinical trials. Approximately 84% of patients remained stable or improved during treatment, with 77% maintaining their clinical stage. The study encapsulated data from 178 patients across diverse U.S. sites, underscoring the drug’s practical applicability in different healthcare settings. The findings also correlated longer treatment durations with better clinical outcomes, providing crucial insights into treatment strategies.

Innovations in Drug Administration: Subcutaneous Dosing

Pioneering the paradigm of drug delivery, Eisai presented findings related to subcutaneous dosing of lecanemab. A novel autoinjector designed for weekly administration has emerged, promising to simplify the treatment process for patients. Data indicated that switching to a 360mg subcutaneous dose following an initial intravenous regimen retained similar efficacy and safety, an exciting prospect for patients who may struggle with frequent IV visits.

Safety Profile: Consistency Over Time

Perhaps the most reassuring aspect of lecanemab’s presentation was the emphasis on its safety profile. Throughout the four-year duration of the studies, no new alarming safety signals emerged. Incidents of amyloid-related imaging abnormalities (ARIA) diminished after the first year and remained steady across multiple treatment modalities.

Looking Ahead

Eisai has played an instrumental role in the global development of lecanemab, ensuring ongoing regulatory assessments and navigating the commercialization process. Meanwhile, BioArctic is solidifying its position for a robust market presence in Nordic countries as they prepare for a collaborative rollout alongside Eisai.

As Alzheimer’s disease continues to affect millions globally, these findings represent a hopeful horizon for patients and caregivers alike, reaffirming the critical importance of continued innovation in Alzheimer's treatment protocols. With extensive trials underway and results anticipated by 2025, the commitment to combating Alzheimer’s through lecanemab may soon reshape the landscape of therapeutic interventions for early-stage Alzheimer’s disease.