The founding executive director and chief science officer at the Alzheimer’s Drug Discovery Foundation discussed the landmark findings from Biogen on its agent aducanumab and the impact the trial might have on the future.
“This is the first time that we’ve really had a really rigorous, well-done trial. If you think about it, all these other trials that failed may have failed because 30% of the people that went into the trial didn’t have the disease. That’s what the data look like.”
In late 2019, data from the phase 3 EMERGE clinical trial suggested that a high-dose regimen of Biogen’s investigational amyloid-beta targeting human monoclonal antibody, aducanumab, reduces the clinical decline of patients with prodromal Alzheimer disease. Although results of the parallel ENGAGE trial reported no effect on clinical decline, post hoc analysis of a subset of patients exposed to high dose aducanumab hints toward support of the EMERGE findings.
Then, earlier this year, Biogen registered a new phase 3b clinical trial of aducanumab, with the FDA giving Biogen the green light to proceed with the re-dosing study as the company seeks to demonstrate the drug’s long-term safety and tolerability in patients with Alzheimer disease. The treatment is now expected to be put forth in a biologics license application (BLA) to the FDA in Q3 of this year.
Howard Fillit, MD, founding executive director and chief science officer, Alzheimer’s Drug Discovery Foundation, told NeurologyLive in a recent interview that this news remains the top of mind for him as the biggest development in dementia thus far. Fillit offered his insight on the landmark findings on aducanumab, and the impact the trial protocols might have on the future.