Results from two Phase 3 clinical trials, EMERGE and ENGAGE, evaluating Biogen’s (BIIB -2.9%) aducanumab in patients with early Alzheimer’s disease (AD) produced different outcomes. The data were presented at the Clinical Trials on Alzheimer’s Disease Conference in San Diego.
In EMERGE, the high dose arm met the primary endpoint of the change from baseline in CDR-SB score at week 78 compared to placebo (p=0.0101) and well as the secondary endpoints of ADAS-Cog 13 and ADCS-ADL-MCI at week 78. The other secondary endpoint, MMSE score, was not met in the larger dataset analysis but did based on the final dataset (p=0.0493). The low dose arm missed all endpoints.
In ENGAGE, both the low dose and high dose arms failed to achieve the primary and all secondary endpoints in either dataset.
The company plans to file a U.S. application based on the totality of the data.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.