Stockholm, February 3, 2021 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have increased the participant target number by approximately 200 in the pivotal Phase 3 study, Clarity AD, of drug candidate lecanemab (BAN2401) for the treatment of early Alzheimer’s disease. The decision was taken proactively to ensure a robust dataset and to mitigate the potential impact of patients who temporarily missed doses due to the COVID-19 pandemic. It was based on a collaborative consultation with the FDA and in accordance with FDA and EMA COVID-19 regulatory guidance. Eisai also confirmed that the screening of participants was completed in January and that time for data readout for Clarity AD remains unchanged and is still expected by September 2022.
During the past year, Eisai has continuously worked to mitigate the challenges posed by the COVID-19 pandemic for the Phase 3 Clarity AD study of drug candidate lecanemab for the treatment of early Alzheimer’s disease, prioritizing patient safety, continuity of dosing, and quality of data. Efforts have included home infusion options and online assessment alternatives. Even so, the pandemic posed a risk that participants in the study would not receive all planned doses or that there could be a lack of data at some assessment time points. Eisai has therefore, after FDA consultation, decided to increase the target number of participants by approximately 200 to ensure a robust dataset. Clarity AD is a double-blind study, and the addition of participants has been implemented without unblinding of any clinical results, and prior to completing enrollment of the original 1566 patient target.
“This past year has been very challenging for everybody, not the least for clinical studies, and I am glad that Eisai has taken the decision to increase the number of participants for the Clarity AD study, to ensure a solid dataset. More than 30 million people around the world suffer from Alzheimer’s disease and we want to do everything we can to provide them with an effective and safe treatment. We look forward to the continued development of lecanemab as a potential disease-modifying treatment for patients with Alzheimer’s disease,” said BioArctic’s CEO Gunilla Osswald.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
This information was submitted for publication at 08:05 a.m. CET on February 3, 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