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Biogen And Eisai's Lecanemab Slows Progression Of Alzheimer's Disease In Phase 3 Trial

Biogen Inc. (BIIB) and Eisai Co., Ltd.'s investigational Alzheimer's disease drug lecanemab could potentially slow the progression of the disease in a large global Phase 3 clinical trial, the companies said in a statement.

Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 in the analysis of Intent-to-treat population. Starting as early as six months, across all time points, the treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo.

According to the companies, all key secondary endpoints were also met with highly statistically significant results compared with placebo. Key secondary endpoints were the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography (PET), the Alzheimer's disease or AD Assessment Scale-cognitive subscale14, AD Composite Score and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment.

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD. The treatment group was administered a dosage of 10 mg/kg bi-weekly of lecanemab, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab. The baseline characteristics of both placebo and lecanemab groups are similar and well balanced.

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