Eisai presents the latest data from the Phase 2b open-label extension study of BAN2401 at AAIC 2020

Stockholm, July 30, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company’s partner Eisai presented the latest data from the open-label extension of the Phase 2b study with the investigational BAN2401 in early Alzheimer’s disease. The preliminary results show, among other things, a continuous decrease in amyloid levels in the brain measured at three, six and twelve months with BAN2401 treatment in those patients who had previously received placebo. The frequency of amyloid-related imaging abnormalities-edema (ARIA-E) during BAN2401 treatment to date in the open-label extension study is comparable to the Phase 2b study. The data were presented at the Alzheimer’s Association International Conference® 2020 (AAIC®) on July 29.

The ongoing open-label extension study (OLE) includes 180 of the patients with early Alzheimer’s disease that were originally included in the Phase 2b study. The aim is to evaluate the long-term safety and tolerability of BAN2401 and brain amyloid levels measured by amyloid PET during continued treatment with BAN2401 at the highest dose used in the Phase 2b study.

At AAIC, preliminary results from ARIA-E and amyloid PET were presented. In the patients randomized to placebo in the Phase 2b study, a rapid decrease in amyloid levels was observed after three months of open-label treatment with BAN2401. After twelve months the observed effect was comparable to the results in patients randomized to start with this dose of BAN2401 in the Phase 2b study. The incidence of ARIA-E, a form of cerebral edema that occurs in patients treated for Alzheimer’s disease, remained low during treatment with BAN2401, and on a similar level as in the core Phase 2b study.

“The new data from the ongoing open-label extension study with BAN2401 further support the effects of our drug candidate on amyloid in the brain. We look forward to the continued development of BAN2401 as a potential disease-modifying treatment for patients with Alzheimer’s disease,” said BioArctic’s CEO Gunilla Osswald.

 Eisai’s presentations from the AAIC congress, which were presented virtually as a consequence of the COVID-19 pandemic, are available on www.bioarctic.com. The material includes the posters from the Phase 2b OLE study as well as the presentation of the design of the new Phase 3 study AHEAD 3-45.

For further information, please contact: 
Gunilla Osswald, CEO, BioArctic AB 
E-mail: gunilla.osswald@bioarctic.se 
Phone: +46 8 695 69 30 

Oskar Bosson, Vice President Communications and Investor Relations, BioArctic AB 
E-mail: oskar.bosson@bioarctic.se 
Phone: +46 70 410 71 80 

This information was submitted for publication at 10:00 a.m. CET on July 30, 2020.