Phase 3 study of lecanemab shows reduction in clinical decline in patients with early AD
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Pharmaceutical companies Biogen and Eisai announced results from a phase 3 trial that demonstrated treatment with lecanemab reduced cognitive decline by 27% after 18 months compared with placebo.
According to an Eisai press release, the investigational anti-amyloid beta protofibril antibody met its primary endpoint and reduced clinical decline on the Clinical Dementia Rating-Sum of Boxes scale in a placebo-controlled, double-blind, parallel-group, randomized study of 1,795 people with early Alzheimer’s disease.
“We feel that these results are really hopeful for Alzheimer’s disease patients,” Michael Irizarry, MD, MPH, senior vice president of clinical research and deputy chief clinical officer of Alzheimer’s disease and brain health at Eisai, told Healio.
“[The data] does suggest that Alzheimer’s disease and potentially other neurodegenerative diseases are tractable,” he said, “that it is possible to impact the progression of these diseases.”
According to the release, trial participants were randomized to receive 10 mg/kg lecanemab biweekly or placebo. After 18 months, those receiving lecanemab had a treatment difference in score change of –0.45.
Lecanemab also met its secondary endpoints, the release said, including change at 18 months in treatment in amyloid levels in the brain measured by amyloid positron emission tomography, the AD Assessment Scale-cognitive subscale14, AD Composite Score and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment.
In response to these results, the Alzheimer’s Association released a statement “enthusiastically” welcoming the data on lecanemab.
“These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date,” the statement read. “These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. Treatments that deliver these benefits to those with mild cognitive impairment due to Alzheimer’s disease and early Alzheimer’s dementia are just as valuable as treatments that extend the lives of those with other terminal diseases.”
Eisai aims to file for traditional approval in the United States and to submit marketing authorization in Japan and Europe by March 2023, according to the company press release.