UNITED STATES: Doctors have heralded the beginning of a “new era” in Alzheimer’s treatments after a clinical trial confirmed that an experimental drug, Lecanemab from Biogen (BIIB.O) and Eisai (4523.T) slows memory decline among patients.
The “momentous” result comes after decades of failure and has sparked a new hope among experts that Alzheimer’s, which affects 30 million people globally, might be treatable.
A new beginning for Alzheimer’s therapy
The drug, Lecanemab, was associated with a risky type of brain swelling in roughly 13% of participants in a trial that lasted 18 months and included over 1,800 patients with early-stage Alzheimer’s.
“This is the first medication that offers a viable therapy option for Alzheimer’s sufferers,” said Bart De Strooper, the director of the U.K. Dementia Research Institute at University College London.
“Although the clinical advantages appear fairly limited, it can be anticipated that they will become increasingly apparent over time,” continued Strooper.
Lecanemab, however, has only a little effect, and its impact on people’s daily lives is still questionable. The drug only works in the early stages of the disease, so most people would miss out without a revolution in spotting the disease.
Some patients also reported brain bleeding, with 14% experiencing microhemorrhages—a symptom linked to two deaths among those taking the medication in a follow-on study.
Lecanemab, an antibody that targets beta-amyloid, a sticky protein clump that builds up in Alzheimer’s patients’ brains, was reported by the manufacturer to have a 27% lower rate of cognitive deterioration than a placebo in September.
Lecanemab is an antibody similar to those that the body produces to fight germs or viruses which instructs the immune system to remove amyloid from the brain.
Amyloid is a protein that clumps in the gaps between neurons in the brain and forms discrete plaques, which is one of the symptoms of Alzheimer’s disease.
Some view the outcomes of this research as a successful turning point in a medical sector littered with failures, despair, and disappointment.
Prof. John Hardy, one of the world’s leading experts who pioneered amyloid targeting 30 years ago, called it “historic” and expressed hope that “we’re seeing the beginning of Alzheimer’s medicines.”
Currently, Alzheimer’s patients are given different drugs to help manage their symptoms, but none alter the course of the illness. 1,795 individuals with early-stage Alzheimer’s disease participated in the large-scale trial. Lecanemab was infused once every two weeks.
The findings, which were presented at the Clinical Trials on Alzheimer’s Disease conference in San Francisco and reported in the New England Journal of Medicine, do not represent a magic cure. Although the disease continued to sap people’s mental capacity, the 18 months of treatment caused that loss to slow by about 25%.
Regulators in the U.S. are already reviewing the data and will make a decision soon on whether Lecanemab can be used more widely. The developers—the pharmaceutical firms Eisai and Biogen—plan to start the approval procedure in other nations next year.
“The information demonstrates that the drug can significantly alter the course of the disease,” said The Alzheimer’s Association, calling on U.S. regulators to approve the company’s request for speedy approval.
Eisai shares gained 3.6% during the Tokyo afternoon trading session, while Biogen shares increased by 0.9%. They have grown by over 60% and 47%, respectively since the trial’s initial data were published in late September.
The full data revealed that some individuals with a hereditary propensity for developing the mind-wasting condition did not benefit from Lecanemab based on the CDR-SB measure.
However, they did demonstrate progress for the trial’s secondary objectives, such as various cognition and daily functioning measures. Lecanemab patients outperformed placebo by 23%–37% on these secondary trial objectives.
Presently, 55 million people are affected by Alzheimer’s disease, and it is estimated that by 2050, there will be more than 139 million people with the disease worldwide.