BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today presented the latest findings for lecanemab (generic name, brand name: Leqembi®). Three-year data show that lecanemab continues to give increased patient benefit for patients with early Alzheimer’s disease with maintained safety profile. In addition, data from the earliest patient cohort showed that 51% of these patients improved their cognition and function score after three years of treatment. The data was presented at the Alzheimer’s Association International Conference (AAIC) 2024, held in Philadelphia, USA, and virtually July 28 – August 1, 2024.
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.
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, and 51% (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]
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.
Oskar Bosson, VP Communications and IR
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