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Sysmex and Eisai aim to develop next-generation diagnostic agents for dementia under a non-exclusive agreement. At the International Conference on Alzheimer's & Parkinson's Diseases, they presented findings on the HISCL™ Automated Immunoassay System. The study demonstrated that the plasma Aβ1-42/Aβ1-40 ratio could predict amyloid PET status with high sensitivity (97.5%) and specificity (80.8%). This advancement could allow for earlier and non-invasive diagnosis of Alzheimer’s disease, improving treatment and monitoring processes.
Eisai and Biogen presented key findings on lecanemab, an investigational antibody for early Alzheimer's disease, at the 2022 AD/PD conference. The studies highlighted lecanemab's clinical efficacy, dosing regimens, and amyloid-related imaging abnormalities (ARIA) rates. Lecanemab demonstrated a rapid and thorough amyloid clearance, with 65% of participants amyloid negative at 12 months. The ongoing Phase 3 Clarity AD trial has 1,795 participants, expecting results in Fall 2022. The FDA granted Breakthrough Therapy designation for lecanemab in 2021.
Eisai Co., Ltd. announced significant developments in its Alzheimer's disease pipeline, focusing on lecanemab, an investigational anti-amyloid beta antibody. The company initiated a rolling submission for a Biologics License Application (BLA) with the FDA under the accelerated approval pathway. Data presentations at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference will explore lecanemab's efficacy and safety, along with biomarker correlations. Key milestones include 1,795 patients enrolled in the Phase 3 Clarity AD trial, and a new subcutaneous dosing Phase 1 study.
Eisai Inc. has announced the presentation of findings from its Alzheimer's disease pipeline, including lecanemab, which received Breakthrough Therapy designation from the FDA. This investigational drug targets amyloid-beta aggregates implicated in Alzheimer's pathology. The findings will be showcased at the 2021 Alzheimer's Association International Conference with 18 presentations scheduled. Eisai is also advancing collaborations with Biogen on clinical studies for ADUHELM and lecanemab, indicating strong momentum in its Alzheimer's franchise.