Stockholm, July 30, 2021 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai held several presentations at the Alzheimer’s Association International Conference (AAIC) in Denver, Colorado July 26 to 30, 2021. The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer’s disease, were presented. Eligibility for the two trials A3 and A45 are dependent on the levels of amyloid in the brain as measured by PET. The results showed that inclusion of subjects for the two trials appear consistent with projections based on existing observational data. The initial experience with screening and randomization from the study also suggests that for trials targeting the underlying pathology of Alzheimer’s disease, it is feasible to identify participants across the stages of preclinical Alzheimer’s disease where patients are at-risk for further amyloid accumulation and the onset of cognitive decline.
For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented. These early results regarding treatment response on clinical outcomes such as ADCOMS, CDR-SB and ADAS-Cog in newly lecanemab-treated and previously treated early Alzheimer’s disease subjects, provide further support for the prior observed placebo-controlled efficacy results in the core study. The data also indicate the need for continuous treatment.
A poster presentation on the ongoing confirmatory Phase 3 Clarity AD study, showed that the baseline characteristics after randomization of 1536 subjects are highly consistent with the Phase 2b study as well as representative of an early Alzheimer’s disease population. In March, Eisai finished recruitment of 1795 patients for Clarity AD, and the readout of the primary endpoint is expected by the end of September 2022.
In another poster presentation results suggested a potential to use the plasma Aβ42/40 ratio to monitor for drug effects in individual patients. The approach will be further assessed in the ongoing lecanemab pivotal studies, Clarity AD & AHEAD 3-45.
“It’s very encouraging to see that Eisai’s broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes. We look forward to the continued development of lecanemab as a potential disease-modifying treatment for patients with Alzheimer's disease,” said BioArctic's CEO Gunilla Osswald.
Eisai's presentations and posters from the AAIC congress 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.
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
The information was released for public disclosure, through the agency of the contact persons above, on July 30, 2021, at 08.00 a.m. CET.