Stockholm, November 9, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today data on the drug candidate BAN2401 (lecanemab), which were presented by the company’s partner Eisai at the Clinical Trials on Alzheimer’s Disease conference (CTAD), November 4-7. The presentations included study design and initial screening results from the Phase 3 study AHEAD 3-45, the baseline characteristics of currently enrolled Alzheimer’s disease patients in the Phase 3 study Clarity AD, and an update on the effect of BAN2401 on amyloid brain levels and the ARIA-E frequency for patients enrolled in the Phase 2b open label extension study.
A presentation on the clinical study design and initial screening results from the newly initiated Phase 3 study AHEAD 3-45, in individuals with preclinical (asymptomatic) Alzheimer’s disease showed that the initial screening results were according to expectations, with more participants joining the A45 trial than the A3 trial. When the study is fully recruited the aim is to have 1000 participants in the A45 trial and 400 in the A3 trial.
A presentation of currently enrolled participants in the ongoing Phase 3 study Clarity AD study in early Alzheimer’s disease patients revealed that the baseline characteristics were consistent with those in the Phase 2b study, and representative of an early Alzheimer’s disease population. These characteristics were presented from the 1222 subjects enrolled in the study as of the beginning of October.
Two presentations covered different aspects of the Phase 2b core and open-label extension study in early Alzheimer’s disease patients. The data showed that patients who received placebo in the Phase 2b core study entered the open-label extension study with high brain amyloid levels. In the open-label extension study, in patients previously on placebo, a rapid decrease in amyloid levels was observed after three months of treatment with BAN2401 10 mg/kg every other week. Further decreases were observed after six- and twelve-months treatment. After twelve months the observed effect was comparable to the results in patients who received this dose of BAN2401 in the Phase 2b core study. For the patients who received BAN2401 10 mg/kg either monthly or every other week in the core study, the amyloid levels in the brain were already low when they entered the open-label extension study and remained low. Also, the incidence of ARIA-E, a form of cerebral edema that occurs in patients treated with anti-amyloid monoclonal antibodies for Alzheimer’s disease, remained on a similar level in the open-label extension study as in the core Phase 2b study, at less than 10 percent. These data are consistent with and expands upon the preliminary results reported at the AAIC (Alzheimer’s Association International Conference®) in July 2020.
“It’s encouraging to see the continued progress and additional data from Eisai’s broad ongoing clinical trial programs for BAN2401 in Alzheimer’s disease. The additional data further support the effects of BAN2401 previously reported from the Phase 2b study. 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 four presentations from the CTAD conference, which were presented virtually as a consequence of the COVID-19 pandemic, are available on www.bioarctic.com.
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 a.m. CET on November 9, 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