The statement below is an update to our May 25, 2018 announcement found here.
Titusville, New Jersey, July 18, 2018 - At Janssen, the safety and well-being of people who participate in our clinical trials are of utmost importance to us.
For the past several years, we have studied an investigational drug, atabecestat, which is a BACE inhibitor. The goal of clinical research with atabecestat was to slow cognitive decline in people at risk for Alzheimer’s dementia.
Elevations of liver enzymes were observed in some study participants who received atabecestat, including two patients who had high elevations of liver enzymes, placing them at increased risk for severe liver injury. These patients remain clinically stable, and their liver enzyme levels have normalized.
After further consideration and consultation with the Dominantly Inherited Alzheimer’s Network Trial Unit (DIAN-TU), and with our development partner, Shionogi, we have decided to stop dosing of patients in the atabecestat arm of the DIAN-TU trial and to fully stop development of atabecestat.
Working closely with the DIAN-TU, we are informing study participants, health authorities, the study ethics committee, and institutional review board about our decision.
Janssen continues to maintain a strong commitment to discovering and developing new treatments for Alzheimer’s dementia.
We are particularly grateful to the people who may be at risk for Alzheimer’s dementia who volunteered to participate in the DIAN-TU study. We also thank their families and study partners, and the DIAN-TU scientists and staff at Washington University in St. Louis, Missouri, and the international investigators for their time and dedication.