Stockholm, October 28, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company’s partner Eisai will conduct four oral presentations related to the drug candidate BAN2401 (lecanemab) at the 13th Clinical Trials on Alzheimer’s Disease Conference (CTAD) on November 4–7. Presentations will include the latest data on BAN2401, as well as the study design and initial screening results from the Phase 3 program AHEAD 3-45 and baseline characteristics of currently enrolled Alzheimer’s disease patients in the Phase 3 study Clarity AD.
During the conference, Eisai will hold four presentations and present new information from all three on-going clinical studies with the investigational anti-amyloid beta (Aβ) protofibril antibody BAN2401;
- The first will cover clinical study design and initial screening results of the newly initiated Phase 3 clinical study AHEAD 3-45 in individuals with preclinical (asymptomatic) Alzheimer’s disease;
- The second will cover baseline characteristics of currently enrolled participants in the ongoing Phase 3 Clarity AD study in early Alzheimer’s disease patients;
- The third will cover results from the latest analysis of amyloid-related imaging abnormalities-edema (ARIA-E) from the Phase 2b core and open-label extension study conducted in early Alzheimer’s disease patients;
- The fourth will cover a preliminary analysis of the effect of BAN2401 on amyloid-levels in the brain and ARIA-E findings observed during the first 12-month treatment period of the ongoing open-label extension of the Phase 2b study.
| Asset in Development, Session Number | Topic/Planned Date and Time(Eastern Standard Time) |
| BAN2401 OC 2 |
The AHEAD 3-45 Study of BAN2401 in Preclinical Alzheimer’s Disease: Study Design and Initial Screening Results November 4 (Wednesday) 10:00 – 10:15AM (live session) 11:25 – 11:40 AM, Live Q&A of oral communications |
| BAN2401 OC 10 |
Baseline Characteristics for Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating BAN2401 in Early Alzheimer’s Disease November 4 (Wednesday) 1:00 PM (on demand) |
| BAN2401 OC 14 |
BAN2401 and ARIA-E in Early Alzheimer’s Disease: Pharmacokinetic/Pharmacodynamic Time-to-Event Analysis from the Phase 2 Study in Early Alzheimer’s Disease November 5 (Thursday) 9:45 – 10:00 AM (live session) 11:15 – 11:30 AM, Live Q&A of oral communications |
|
BAN2401 |
Preliminary Analysis of BAN2401 Effects on Brain Amyloid and ARIA-E Findings Over 12 Months of Treatment in the Open-Label Extension of the Phase2b Study BAN2401-G000-201 in Subjects with Early Alzheimer’s Disease November 7 (Saturday) 12:10 AM – 12:25 PM (live session) 12:25 – 12:50 PM, Live Q&A of late breakers |
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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 08:00 am CET on October 28, 2020.
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