Biogen and Eisai Co., Ltd. announced that Biogen presented results at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, in Barcelona, Spain, from the recent 36- and 48-month analyses of the ongoing long-term extension (LTE) of the Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD.
A late-breaking oral presentation and a poster included data from patients treated with aducanumab for up to 36 and 48 months. Data from both analyses showed a reduction in amyloid plaque levels in a dose- and time-dependent manner, as measured by positron emission tomography (PET). In addition, analyses of exploratory clinical endpoints, Clinical Dementia Rating Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE), suggested a continued slowing of clinical decline over 36 months and 48 months. The results in each dosing arm were generally consistent with previously reported analyses of this study, and there were no changes to the risk-benefit profile of aducanumab.
“This Phase 1b study now has four years of aducanumab results, and we are encouraged by these data, which continued to show a reduction in amyloid plaque levels and suggest our investigational therapy may slow clinical progression of the disease,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “The Phase 3 studies are now fully enrolled, and we remain driven by the profound unmet needs of patients, families, caregivers and society.”