Biogen and Eisai have made the decision to discontinue two phase 3 trials evaluating aducanumab for the treatment of mild cognitive impairment due to Alzheimer disease (AD) and mild AD dementia.
The decision was based on the results of a futility analysis which indicated that the studies (ENGAGE and EMERGE) were unlikely to meet the primary endpoint of slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. “This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience,” said Michel Vounatsos, Chief Executive Officer at Biogen.
Aducanumab, a human recombinant monoclonal antibody derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline, was also being evaluated in the phase 2 EVOLVE trial and the long-term extension of the phase 1b PRIME trial; both of these studies have also been discontinued.
According to the Companies, following further assessment of the data, a decision on whether a phase 3 secondary prevention trial should be initiated will be made. Data from the ENGAGE and EMERGE studies will be presented in greater detail at upcoming medical conferences.
For more information visit Biogen.com.
This article originally appeared on MPR