A recent announcement from pharmaceutical manufacturers Biogen and Eisai brings promising news to those affected by Alzheimer’s. The companies made a statement in late September regarding the progress of a drug, Lecanemab, being developed to mitigate cognitive decline in patients suffering from the disease.
In it, representatives from the collaboration touted the results of a recently completed late-stage clinical trial, saying the new data proved the medication’s efficacy across a sample of nearly 2,000 participants. As it awaits a decision via the Food and Drug Administration’s (FDA) accelerated approval program, Eisai says it will work toward preparing the next round of trials before eventually submitting for an official FDA rubber stamp.
Lecanemab looks to build on Biogen’s work to develop Aduhelm, an earlier iteration met with criticism due to lack of reported effectiveness.
Both substances were intended to facilitate clearing up any plaques in the brains of those with the disease. These buildups come from a slow accumulation of what are called amyloid proteins. The drug functions as an antibody to these neurotoxic lumps, thus allowing for a less accelerated disease progression rate in the patient.
This study, which looks to build a far more convincing set of data than was present during Aduhelm’s approval process, involved 1,800 volunteer participants who agreed to be observed at different intervals over 18 months. Many participants had Alzheimer’s in varying stages, though some present only had relatively minor cognitive impairments.
What played out next was significant. Throughout the study, participants who received Lecanemab displayed cognitive rates of decline that were slowed by an estimated 27% compared to those with the placebo. This nearly 30% difference can mean a notable extension of a patient’s precious months of lucidity, allowing them more control over their circumstances.
“That amounts to an extra six months or so in which they can cook a meal, use a computer or pay their bills,” said Dr. Christopher Van Dyck, who works as director of the Alzheimer’s Disease Research Unit at Yale School of Medicine.
Lecanemab’s promise marks a foray into areas of Alzheimer’s research that are new and exciting for the field. It is also a potential turning point for a company like Biogen, which found itself struggling to find its footing after the failures of Aduhelm.
“For Biogen, it puts them back in the Alzheimer’s game,” said Brian Skorney, Baird market analyst.
The billion-dollar potential of a drug that slowed Alzheimer’s-related cognitive decline — the first of its kind in medicine — is far from lost on Biogen partner Eisai. In September’s announcement, chairman and CEO Ivan Cheung voiced his excitement over what he claimed was “the first definitively positive large clinical trial to show that you can indeed slow down Alzheimer’s disease at this very early symptomatic stage.”
The study’s success bodes well for AHEAD, a project from Biogen and Eisai with help from the National Institutes of Health and the U.S. Alzheimer’s Clinical Trial Consortium. AHEAD looks instead to the youngest side of the Alzheimer’s process, the pre-symptom stage.
Dr. Reisa Sperling, who heads the trial, says Lecanemab was initially chosen for AHEAD in 2019 due to its high safety ratings. This new data has made for a great deal of optimism in her camp, which was awaiting the results with bated breath in hopes of even a small sign of efficacy. As Sperling sees it, this update could fundamentally change outcomes for the disease.
“If we saw that same slowing at the preclinical stage of Alzheimer’s disease, most people wouldn’t develop dementia in their lifetime — or at least a substantial proportion would not,” she said.