Stockholm, July 22, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company’s partner Eisai will present the study design of the Phase 3 program AHEAD 3-45 at the Alzheimer’s Association International Conference 2020 (AAIC®) on July 27–31. In the study, the therapeutic effect of drug candidate BAN2401 (an anti-amyloid beta protofibril antibody) on the progression of preclinical, asymptomatic, Alzheimer’s disease will be investigated. Additionally, Eisai will present interim results from the open label extension study of the Phase 2b study with BAN2401 in early Alzheimer’s disease.
AHEAD 3-45 is a groundbreaking Phase III clinical study, conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium (ACTC), which is funded by the National Institute on Aging (NIA), part of the US National Institutes of Health, and Eisai. The Phase 3 program consists of two NIA-funded clinical trials, A3 and A45, and will evaluate the therapeutic effects of BAN2401 on the progression of preclinical, asymptomatic, Alzheimer’s disease. The same drug candidate is also being studied in a pivotal Phase 3 clinical study in symptomatic early Alzheimer’s disease (Clarity AD).
Eisai will also present interim results from an ongoing open label extension study of the Phase 2b trial of BAN2401 in early Alzheimer’s disease. The presentations will include preliminary results concerning the effect of BAN2401 on amyloid levels in the brain as well as the frequency of ARIA-E (brain edema) in the patient group.
| Presentation | Date | |
| Oral Presentation Oral #44511 Session O2-09 Presentation O2-09-05 |
AHEAD 3-45 Study Design: A Global Study to Evaluate Efficacy and Safety of Treatment with BAN2401 for 216 Weeks in Preclinical Alzheimer’s Disease with Intermediate Amyloid (A3 Trial) and Elevated Amyloid (A45 Trial) | Wednesday, July 29 |
| Poster #46059 Session P3-01 |
A Preliminary Account of ARIA-E in the Ongoing Open Label Extension Phase of BAN2401-G000-201 in Subjects with Early Alzheimer’s Disease | Wednesday, July 29 |
| Poster #46209 Session P4-01 |
A Preliminary Assessment of Longitudinal Amyloid Status in the Ongoing Open-Label Extension Phase in Subjects with Early Alzheimer’s Disease | Wednesday, July 29 |
—
This information was submitted for publication at 08:00 a.m. CET on July 22, 2020.
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.
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