An optimistic trend reported from the experimental drug lecanemab (BAN2401) clinical trials broaches the question of when the joint asset of Eisai Co., Ltd. and Biogen Inc. will hit the market.
An optimistic trend reported from the experimental drug lecanemab (BAN2401) clinical trials broaches the question of when the joint asset of Eisai Co., Ltd. and Biogen Inc. will hit the market.
Eisai Vice President Michael Irizarry, M.D. promises focused efforts to accelerate its delivery. The study result was recently published in the Alzheimer’s Research and Therapy journal as “A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-Aβ Protofibril Antibody.”
The article described evidence of consistently reduced deposits of the brain amyloid beta (Aβ) peptides among patients with early onset of Alzheimer’s disease during this phase of the Clarity AD study. Slowed neurological decline was observed consequently with the use of lecanemab (BAN2401).
Phase III of this study will primarily aim to confirm these results. It will also ascertain long-term safety and tolerability in using lecanemab (BAN2401) during its extension phase.
The roadmap for Phase III Clarity AD targets primary completion by June 30, 2022. The study is estimated to be completed by August 29, 2024. The first participants were enrolled in the trials on March 27, 2019.
The relationship between the amyloid beta peptides and Alzheimer’s disease is the main contention in the amyloid cascade hypothesis, which was posed in 1992 by John A. Hardy and Gerald A. Higgins. In this, the co-authors presented that deposits of amyloid beta peptides are critical to the Alzheimer’s disease pathogenesis.
Parallel to Phase III Clarity AD is Phase III AHEAD 3-45, which runs the clinical trials among participants who have been characterized with pre-clinical Alzheimer’s disease. This study is jointly funded by the U.S. National Institutes of Health (NIH) and Eisai Co Ltd. subsidiary Eisai Inc.
Paul Aisen, co-lead of the AHEAD 3-45 study and director of USC’s Alzheimer’s Therapeutic Research Institute (ATRI), explained that the goal is to confirm the effect of removing amyloid on the cognitive health and Alzheimer’s disease markers on individuals before the set in of irreversible neurological damage.
Amyloid accumulation begins the disease process, and it predicts progressive cognitive decline to dementia. All of the known genetic causes of Alzheimer’s disease are tightly linked to amyloid accumulation,” Aisen said.
The study leverages evidence provided by normalized amyloid PET scans after treatment with lecanemab (BAN2401).
Phase III AHEAD 3-45 trials started in July 2020. As with the Phase III Clarity AD trial, the study will run clinical trials for four years. It has 1,400 participants, who were selected from 9,000 recruits from 100 global sites.
“We are working to advance lecanemab and our other targeted investigational compounds as quickly as possible in our commitment to bringing solutions to patients and their families,” said Michael Irizarry, M.D., Deputy Chief Clinical Officer of the Neurology Business Group at Eisai Inc.
Esai is set to present data from its aggregated efforts on neurology solutions at the 73rd Annual Meeting of the American Academy of Neurology (AAN). The virtual event is set for April 17-22, 2021. Anticipated inclusions are data that the company’ has gathered not just on Alzheimer’s disease but also on insomnia and epilepsy.
