Stockholm April 20, 2021 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-Aβ Protofibril Antibody, in the peer-reviewed journal Alzheimer’s Research & Therapy. The manuscript describes results from Study 201, a Phase 2b proof-of-concept study that explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline in patients with early Alzheimer’s disease. The manuscript concluded that the analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the pivotal Phase 3 study Clarity AD aims to confirm.
The lecanemab Clarity AD Phase 3 study completed enrollment last month with 1,795 symptomatic patients with early Alzheimer’s disease. Clarity AD is a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase designed to confirm safety and efficacy of lecanemab in subjects with early Alzheimer’s disease. Eisai expects the 18-month results to be available in September 2022. Additionally, the Phase 3 AHEAD 3-45 study is currently exploring lecanemab in individuals with preclinical Alzheimer’s disease, defined as persons that are clinically asymptomatic, but have intermediate or elevated brain Aβ levels.
“It’s great to see the promising results from the Phase 2b study published. The aim of the Clarity AD study is to confirm these results, thereby offering a disease modifying treatment to millions of Alzheimer’s disease patients around the globe, which have no such treatment available today,” said Gunilla Osswald, CEO, BioArctic.
The information was submitted for publication at 08:00 am CET on April 20, 2021.
For further information, please contact:
Gunilla Osswald, CEO, BioArctic AB
Phone: +46 8 695 69 30
Oskar Bosson, Vice President Communications and Investor Relations, BioArctic AB
Phone: +46 70 410 71 80