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New global Phase 3 program of BAN2401 initiated in preclinical (asymptomatic) Alzheimer’s disease

Non Regulatory

Stockholm, July 14, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that its business partner Eisai, in collaboration with Alzheimer’s Clinical Trials Consortium (ACTC) and Biogen, has initiated a new global Phase 3 clinical study (AHEAD 3-45) with BAN2401, an anti-amyloid beta (Aβ) protofibril antibody. The study will evaluate the therapeutic effect of BAN2401 on the progression of Alzheimer’s disease in individuals in preclinical (asymptomatic) stages of the disease. They are clinically normal and have intermediate or elevated levels of amyloid in their brains. BAN2401 is currently being studied in a pivotal Phase 3 clinical study in symptomatic early Alzheimer’s disease (Clarity AD), following the favorable outcome of the Phase 2b clinical study. The AHEAD 3-45 study will be conducted in the US, Canada, Japan, Australia, Singapore and Europe.

The AHEAD 3-45 program consists of two trials, A3 and A45, which aim to evaluate the potential of BAN2401 to reduce accumulation of harmful amyloid beta aggregates in the brain and prevent cognitive decline due to Alzheimer’s disease. After a common screening process in AHEAD 3-45, participants can be enrolled into one of the two randomized, double-blind, placebo-controlled trials based on the level of amyloid in the brain. A total of 1400 participants will be enrolled in the study.

The A3 trial will enroll participants who have an intermediate amount of amyloid in the brain, and who are at high risk for further amyloid beta accumulation, and thus at risk for developing clinical symptoms of Alzheimer’s disease. The aim of the trial is to evaluate the potential of BAN2401 to stop or reduce aggregation of harmful amyloid beta in the brain before any clinical symptoms develop.

The A45 trial will enroll participants with elevated levels of amyloid beta in the brain. The aim of the trial is to measure the effect of BAN2401 in preventing cognitive decline and suppressing progression of Alzheimer’s disease pathology in the brain.

“We welcome the initiative to perform this new and extensive Phase 3 program with BAN2401. In contrast to the Clarity AD study, AHEAD 3-45 will investigate BAN2401 as a potential preventive treatment in the pre-symptomatic stages of the disease continuum. A successful outcome would provide opportunities to treat patients at a very early stage, or even preventing the disease, thereby substantially reducing patients’ suffering and providing substantial cost savings for society at large,” said Gunilla Osswald, CEO, BioArctic AB.

ACTC is funded by NIA grant number R01AG054029. A3 is funded by a public-private partnership between Eisai and the NIA (grant number R01AG054029). A45 is funded by a public-private partnership between Eisai and the NIA (grant number R01AG061848) through the ACTC.

This information was submitted for publication at 08:00 a.m. CET on July 14, 2020.

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