Chad J. Swanson, United States of America
Eisai, Inc Neurology Business GroupModerator of 1 Session
Presenter of 2 Presentations
LIVE DISCUSSION
PRELIMINARY AMYLOID PET ANALYSIS IN BAN2401 PHASE 2 OPEN-LABEL EXTENSION IN SUBJECTS WHO PARTICIPATED IN THE CORE IMAGING SUBGROUP
Abstract
Aims
To evaluate preliminary findings for BAN2401, a humanized IgG1 monoclonal antibody that selectively binds Aβ protofibrils, to evaluate the longitudinal amyloid positron emission tomography (PET) findings in subjects who participated in the Core amyloid imaging subgroup.
Methods
A total of 39 subjects who participated in the Core imaging subgroup are evaluated in the Open Label Extension (OLE) imaging subgroup (Core allocation: placebo:10; 10 mg/kg monthly:19; 10 mg/kg biweekly:10). All subjects received 10 mg/kg biweekly for up to 12 months in the OLE. All subjects were amyloid positive at baseline in the core study based on PET visual read. Piecewise regression analyses were conducted on amyloid PET standard uptake value ratio (SUVr) over the 18-month core period, at baseline of the OLE, and over 12 months during the OLE.
Results
Reductions were dependent on Core treatment assignment and PET SUVr at OLE baseline, with model-estimated slope for change from baseline SUVr of -0.026 in Core placebo-treated subjects, compared to -0.004 in Core 10 mg/kg biweekly-treated subjects over the 12-month OLE. Change from core baseline point estimate SUVr values for Core placebo-treated subjects were 0.05022, -0.027, -0.104, and -257 at OLE baseline, 3, 6, and 12 months, respectively, in the OLE. Point estimate SUVr values for Core BAN2401-treated subjects changed less relative to OLE baseline over the 12-month OLE.
Conclusions
Results from this preliminary analysis suggest that 10 mg/kg biweekly BAN2401 elicits rapid reduction of brain amyloid that is apparent as early as 3 months of treatment.