On 11 November, Eisai and Biogen have announced that new data on lecanemab (also known as BAN2401), their investigational antibody targeting amyloid beta for the treatment of Alzheimer's disease (AD), have been presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference. Data presented from the open label extension study (OLE) of the Phase IIb study of lecanemab, in people with early AD showed a reduction of brain amyloid, seen in brain scans as early as after three months of treatment and the amyloid clearance with more than 80% of participants being amyloid negative after 12 months treatment in the OLE. The study has a duration of five years.
Baseline characteristics from the Clarity-AD Phase III trial, evaluating BAN2401 in people with mild cognitive impairment due to AD or mild AD dementia with confirmed amyloid accumulation in the brain, were also presented at CTAD. Data presented from 1,795 participants enrolled in the study were consistent with those of the Phase IIb study. Top-line data are expected by end of September 2022.In addition, data presented showed the potential to use blood tests with Aβ42/40 ratio to monitor the treatment effect of lecanemab. This blood biomarker is used in the screening of participants of the ongoing AHEAD 3-45 Phase III clinical trial. This study started in July 2020 and aims to evaluate the efficacy of lecanemab in people who are clinically normal but have intermediate or elevated amyloid levels in the brain. The plasma Aβ42/40 ratio demonstrated very good ability to predict amyloid PET levels and determine eligibility for the AHEAD 3-45 study.
