Drug makers Biogen Inc. (BIIB) and Japan’s Eisai Co., Ltd. (ESALY.PK, ESALF.PK) announced Friday new analyses from the Phase 3 Clarity AD study of lecanemab, as well as three additional detailed analyses from the Phase IIb clinical study of lecanemab.
Eisai presented the new analyses from the Phase 3 Clarity AD study of lecanemab at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases annual meeting AD/PD.
Further, the three additional detailed analyses from the Phase IIb clinical study or Study 201, evaluating the efficacy and safety of lecanemab for mild cognitive impairment or MCI due to Alzheimer’s disease or AD and mild AD, were published in the peer-reviewed journals.
Eisai serves as the lead of lecanemab development and regulatory submissions globally. Both Eisai and Biogen co-commercializeg and co-promote the product, while Eisai have final decision-making authority.
Regarding the Phase 3 Clarity AD study of lecanemab, the companies said Eisai presented the new analyses on amyloid-related imaging abnormalities or ARIA with the use of antiplatelet and anticoagulant medications, isolated ARIA-H, and caregiver burden and health-related quality of life or QOL from the trial results.
Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD. Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.
In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo. The objective of the analysis was to evaluate antiplatelet and anticoagulant medication use in participants who experienced either ARIA-E (edema) or ARIA-H.
In Japan, Eisai shares were gaining around 2 percent to trade at 7,548 yen.
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