Aducanumab
Monoclonal antibody | |
---|---|
Source | Human |
Target | Beta-amyloid |
Clinical data | |
Identifiers | |
1384260-65-4 | |
None | |
Chemical data | |
Formula | C6472H10028N1740O2014S46 |
145.9 kDa |
Aducanumab is a human monoclonal antibody designed for the treatment of Alzheimer’s disease (AD).[1] It is being developed by Biogen in collaboration with Neurimmune, which licensed the compound to Biogen. It targets aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque found in the brain of AD patients.
Clincal Trials
The Phase 1b clinical trial of Aducanumab, known as PRIME, in an ongoing randomized, double-blind, placebo-controlled, dose-dependent study which aims to evaluate the safety and tolerability of the drug while also measuring the phamacokinetics and pharmacodymanics. The target population includes patients with prodromal or mild Alzheimer's disease. The trial began recruiting patients in June of 2011. Interim results indicate that Aducanumab has a dose and time dependent reduction effect in the reduction of amyloid plaque. A composite standardized uptake value ratio uses PET imaging to compare amyloid plaque volume throughout the study. The results show a significant decrease in amyloid plaque volume in the 3mg/kg [-0.139 (p<0.001)] and 10mg/kg [-0.266 (p<0.001) groups at 54 weeks, when compared to placebo. Both the 3mg/kg and 10mg/kg groups also displayed significant slowing of cognitive decline.[2]
Criticism
Though Aducanumab demonstrated an "acceptable" safety and tolerability profile, there are concerns that the most frequently reported adverse event, a type of edema known as amyloid-related imaging abnormalities (ARIA), may pose a serious risk as it appears to be both time and dose dependent. There are also concerns that certain numbers used in the data analysis as well as circumstances in the trial may betray the truth that Aducanumab is not as efficacious as the results suggest.[3]
References
- ↑ Statement On A Nonproprietary Name Adopted By The USAN Council - Aducanumab, American Medical Association
- ↑ Biogen Idec Presents Positive Interim Results from Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab (BIIB037) at 2015 AD/PD™ Conference, "BusinessWire"
- ↑ Biogen Drug Could Inspire New Hope For Alzheimer's Treatments, "Forbes"
|