Study Suggests Late Stage Asset Could Delay Progression of Alzheimer’s Dementia
New research published in Neurology and Therapy suggests that treatment with anti-amyloid-beta protofibril antibody lecanemab (BAN2401) is estimated to slow the rate of disease progression in patients with Alzheimer’s Disease (AD). Lecanemab is a drug in development through the collaboration of BioArctic and Eisai.
In patients with AD, plaques and tangles form in the brain, contributing to cell death and destruction, leading to its devastating symptoms. Plaques are created by protein deposits, amyloid-beta, and tangles are formed by aggregates of misfolded protein cells called tau. Although it’s unclear why these plaques and tangles form in patients, they are an essential target in therapeutic efforts.
Lecanemab is a humanized monoclonal antibody that specifically targets amyloid-beta. The drug binds to the protein aggregates and then neutralizes and eliminates them, making it a drug that has the potential to slow the progression of AD and stop some of the harmful pathologies of the disease. Eisai obtained the global rights to study, develop and manufacture lecanemab under an agreement concluded with BioArctic in December 2007.
The drug was granted Fast Track Designation in December 2021 by the U.S. Food and Drug Administration. The company anticipates completing a rolling biologics license application in the second quarter of 2022. Clinical trials are supported by the Alzheimer’s Clinical Trial Consortium and the National Institute of Aging.
Currently, lecanemab is being studied in Phase III clinical trials in symptomatic early AD and is being investigated in a separate Phase III clinical trial, which evaluates the therapeutic in patients with asymptomatic AD. In March 2022, Eisai presented data from its Phase IIb trial of the drug showing that it demonstrated the ability to clear amyloid plaques and determined a dose that was most likely to slow AD-associated cognitive decline. The drug also demonstrated a favorable safety and tolerability profile, with only mild to moderate adverse events being reported.
Now, the companies are demonstrating lecanemab’s potential to delay AD dementia by years. Although only tested using a simulation of 1,735 patient profiles, the companies were able to demonstrate that lecanemab could slow the rate of disease progression and shorten the duration a patient would be considered to have moderate and severe AD dementia. In the model, the average time of advancing to mild, moderate and severe AD dementia was longer for patients taking the therapeutic by at least two years. Additionally, the model precited a lower lifetime probability of being admitted to institutional care while taking lecanemab.
“The results from the simulation done by Eisai demonstrate the potential clinical value of lecanemab for patients with early AD and how it could slow the rate of disease progression, delay progression to AD dementia with several years and reduce the need for institutionalized care,” Gunilla Osswald, CEO of BioArctic said in a statement.
Osswald also noted that the Phase III clinical trial outcome would be essential to refining the model of disease using lecanemab. Results from the ongoing trial are anticipated in September 2022.
Apr 27, 2022
