Alzheimer's Disease Drug Development Pipeline 2020
Marwan N. Sabbagh
Abstract
On March 21, 2019, the aducanumab development team conducting the EMERGE and ENGAGE studies announced that the trials had met a pre-specified futility endpoint (1). The consequences of that announcement were far reaching, as many companies that had invested heavily in targeting amyloid were left to consider if targeting amyloid still remained a viable strategy for developing effective Alzheimer’s disease (AD) therapeutics. Following that announcement, the remaining BACE inhibitor trials announced safety concerns or efficacy concerns effectively ending elenbecestat, umibecestat, lanabecestat, atabecestat, and verubecestat as possible treatments for AD (2). Given that gamma secretase inhibitors and modulators had failed in the past, altering or halting production of amyloid appears to no longer offer viable therapeutic benefits moving forward. To further complicate this already troubling situation, the TMS/cognitive stimulation treatment combination (3) has not received FDA approval.