Wednesday 28 September 2022 04:38 AM Experimental drug hoped to be the first to significantly slow decline of ... trends now

Wednesday 28 September 2022 04:38 AM Experimental drug hoped to be the first to significantly slow decline of ... trends now
Wednesday 28 September 2022 04:38 AM Experimental drug hoped to be the first to significantly slow decline of ... trends now

Wednesday 28 September 2022 04:38 AM Experimental drug hoped to be the first to significantly slow decline of ... trends now

An experimental Alzheimer's drug developed by Eisai Co Ltd and Biogen Inc significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, the companies said on Tuesday.

The injected drug, lecanemab, slowed progress of the brain-wasting disease by 27 percent compared to a placebo, meeting the study's main goal, and offering an apparent win for the companies and potentially for patients and their families desperate for an effective treatment.

Eisai said the results from the 1,800-patient trial prove 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.

Analysts, such as Salim Syed at Mizuho Securities, have said the results would be considered a 'win' if lecanemab slowed the rate of decline by around 25 percent, and that shares of both companies could jump on the news.

Lecanemab, like the companies' previous drug Aduhelm, is an antibody designed to remove those amyloid deposits. 

Unlike Aduhelm, lecanemab targets forms of amyloid that have not yet clumped together.

An experimental Alzheimer's drug, called lecanemab, has significantly slowed cognitive and functional decline by 27 percent in a large patient trial

An experimental Alzheimer's drug, called lecanemab, has significantly slowed cognitive and functional decline by 27 percent in a large patient trial

Analysts, such as Salim Syed (pictured) at Mizuho Securities, says a 25 percent decline would be a 'win'

Analysts, such as Salim Syed (pictured) at Mizuho Securities, says a 25 percent decline would be a 'win'

Results from a 1,800 patient trial proved the theory that removal of sticky deposits of protein called amyloid beta can delay the debilitating disease

Results from a 1,800 patient trial proved the theory that removal of sticky deposits of protein called amyloid beta can delay the debilitating disease 

Alzheimer's disease is a progressive, degenerative disease of the brain, in which build-up of abnormal proteins causes nerve cells to die

Alzheimer's disease is a progressive, degenerative disease of the brain, in which build-up of abnormal proteins causes nerve cells to die

The so-called amyloid hypothesis has been challenged by some scientists, particularly after the U.S. Food and Drug Administration's controversial approval of Aduhelm in 2021 based on its plaque-clearing 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.

Aduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry.

Eisai, leader of the 50-50 partnership's lecanemab program, is seeking FDA approval under the same accelerated pathway as Aduhelm, with a decision expected in early January. 

But on Tuesday the Japanese drugmaker said it will use the new efficacy results to submit lecanemab for traditional FDA review.

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

The Phase III trial evaluated the drug's ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as

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