CMC on the Verge of Alzheimer’s Game-Changer

Failed Alzheimer’s study could have led to disease modifying medication

Pharmaceutical company, Biogen, recently revealed a plan to resurrect its experimental Alzheimer’s drug, aducanumab, months after the study’s failure and abrupt closure.

Biogen began using aducanumab in 2017 to remove sticky proteins in the brain, called beta amyloid, that are linked to Alzheimer’s disease. Aducanumab (BIIB037) is a human monoclonal antibody studied for the treatment of early Alzheimer’s. Columbus Memory Center was one of the first in the world to enroll in the initial study, which halted operations in March 2019. The March closure dimmed the light of hope for the more than 3,200 global study participants, caregivers and the Alzheimer’s research industry alike.

At the time, researchers believed the therapy had no chance of succeeding due to failure of a futility analysis done on an earlier, smaller dataset. However, teams have since analyzed a larger group of data and determined that aducanumab is indeed active pharmacologically and clinically.

“This is a result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,” explained Michel Vounatsos, Chief Executive Officer at Biogen, Inc.

The company’s unprecedented reversal and larger plan to offer aducanumab to eligible patients, who were previously enrolled in the clinical studies, sent shockwaves through the Alzheimer’s community. “I have to pinch myself because I almost don’t believe it yet,” Al Sandrock, Biogen’s Chief Medical Officer shared.

While the reversal is unprecedented, Sandrock says he’s already shared the new data with the FDA, who has provided commentary that ultimately led to the public announcement. An announcement that Dr. Jonathan Liss, founder of Columbus Memory Center, says could be a game changer.

Biogen plans to submit a Biologics License application to the Federal Drug Administration (FDA) in early 2020. If approved, the formerly shelved medication could make its way to the bedsides of Alzheimer’s patients soon after.

If approved, aducanumab would be the first medication to reduce the clinical decline of Alzheimer’s. Consequently, aducanumab’s approval would also be the first therapy to confirm the link between reduced beta amyloid in the brain and improved cognition for Alzheimer’s sufferers.