An experimental Alzheimer’s treatment, code named BIIB037 (also known as aducanumab, an amyloid antibody), has shown some encouraging improvements in cognition for patients during a small, preliminary Phase I trial conducted by Biogen Idec.
The improvement in cognition for Alzheimer’s patients taking aducanumab was statistically significant, so this will be an interesting Alzheimer’s drug candidate to watch over the next few years as Biogen moves to a much larger, much longer, (and much more expensive) Phase III clinical trial.
A successful Alzheimer’s treatment is a very pressing issue as the entire global population is now aging at a far faster rate, and attempts to stall the disease with new drugs has been met with several spectacular failures.
The Long, Risky Journey to FDA Approval
Biogen faces a perilous road ahead, as they test the drug on a much larger group of patients during the Phase III trial period. It’s important to note that aducanumab is a potential *treatment* for Alzheimer’s, but it is not a cure for the disease.
The major risks of the drug include headaches and serious brain swelling, especially in a subset of patients who carry the APOE4 gene variant, which is linked to a higher risk of developing late-onset (after age 65) Alzheimer’s disease. Unfortunately, this may mean that aducanumab at therapeutic doses could be lethal to the very people who need it most.
All the safety and efficacy issues with aducanumab will have to sorted out during the Phase III trial. We believe the earliest availability of the drug will be in 2020, assuming near perfect trial results.
Stay tuned for further updates on Alzheimer’s drug trial progress.
See also: Rethinking a Cure for Alzheimer’s Disease