Hopeful signs from Alzheimer’s drug trial

ROCHESTER: Eisai and Biogen said yesterday their experimental Alzheimer’s drug significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, marking a rare win in a field littered with failed drugs.

The drug, Lecanemab, slowed progress of the brainwasting disease by 27% compared with a placebo, meeting the study’s main goal, and potentially offering hope for patients and their families desperate for an effective treatment.

Eisai said the results from the 1800patient trial proved the longstanding theory that removal of sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s can delay advance of the debilitating disease.

‘‘It’s not a huge effect, but it’s a positive effect,’’ Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center in Minnesota, said.

‘‘This means that treating amyloid is a step in the right direction,’’ he said.

Shares of Biogen and Eisai were halted, but shares of Eli Lilly, which is also developing an Alzheimer’s drug, was up 6.7% in afterhours trade.

Lecanemab, like the companies’ previous drug Aduhelm, is an intravenous antibody designed to remove those amyloid deposits. Unlike Aduhelm, Lecanemab targets forms of amyloid that have not yet clumped together.

‘‘If you can slow a disease by almost 30% that’s fantastic. This is what we have been looking for,’’ Dr Jeff Cummings, director for the ChambersGrundy Center for Transformative Neuroscience at the University of Nevada, said.

The socalled amyloid hypothesis has been challenged by some scientists, particularly after the US Food and Drug Administration’s controversial approval of Aduhelm in 2021 based on its plaqueclearing ability rather than proof that it helped slow cognitive decline. The decision came after the FDA’s own panel of outside experts had advised against approval.

Patient advocacy groups hailed the news of positive Lecanemab trial results.

‘‘This is important because it demonstrates that each of these drugs is different . . . I would hope that the FDA approves the drug in January,’’ US Against Alzheimer’s chairman George Vradenburg said.

Aduhelm was the first new Alzheimer’s drug approved in 20 years after a long list of highprofile failures for the industry.

Eisai, leader of the 5050 partnership’s Lecanemab programme, is seeking FDA approval under the same accelerated pathway as Aduhelm, with a decision expected in early January.

The Japanese drugmaker said yesterday it would use the new efficacy results to submit

Lecanemab for traditional FDA review as well.

The company said it would also seek authorisation in Japan and Europe during its current fiscal year, ending March 31.

The phase 3 trial evaluated the drug’s ability to reduce cognitive and functional decline based on the clinical dementia ratingsum of boxes (CDRSB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgement, problemsolving and personal care.

Globally, those living with Alzheimer’s could rise to 139 million by 2050 without an effective treatment, Alzheimer’s Disease International said. — Reuters.