Eisai, Biogen and the Alzheimer’s Clinical Trials Consortium (ACTC) have initiated a new Phase III clinical trial of BAN2401 to treat preclinical Alzheimer’s disease (AD) in the US.
Named AHEAD 3-45, the study will enrol participants who are clinically normal with intermediate or elevated levels of amyloid in their brains.
BAN2401 is a humanised, monoclonal, anti-amyloid beta (Aβ) protofibril antibody. It is currently being studied in a pivotal Phase III trial in symptomatic early AD (Clarity AD), after its outcome in the Phase II study (Study 201).
The drug candidate was obtained under a research alliance between Eisai and BioArctic.
Apart from the US, the new Phase III trial will be performed in Japan, Canada, Australia, Singapore, and Europe.
Eisai Neurology Business Group chief clinical officer Lynn Kramer said: “The initiation of AHEAD 3-45 with BAN2401, focused on therapies for the earliest stages of the AD continuum through our collaboration with the ACTC group, marks an exciting time for us.
“This represents a next step in developing precision therapies for AD using biomarker panels as part of our human health care mission, we are committed to making a difference for patients, their families, and health care professionals across the globe.”
AHEAD 3-45 is being performed as a public-private partnership between the ACTC, funded by the National Institute on Aging, and Eisai.
Depending on the amyloid level in the brain, participants will be enrolled into the randomised, double-blind, placebo controlled A45 trial or the A3 trial. The aim is to recruit a total of 1,400 participants to receive BAN2401 for 216 weeks.
The A45 trial will involve cognitively unimpaired participants with elevated amyloid levels in the brain. This study is intended to use BAN2401 to prevent cognitive decline and suppress the progression of brain AD pathology.
Meanwhile, the A3 trial will involve cognitively unimpaired participants having intermediate amount of amyloid in the brain and are at high risk for further Aβ accumulation.
In September last year, Eisai and Biogen decided to stop Phase III studies of beta amyloid cleaving enzyme (BACE) inhibitor elenbecestat in patients with early AD.