J&J stops trial of BACE for Alzheimer’s disease to enter the list of failed drugs

Jannsen, the Pharmaceutical arm of Johnson and Johnson, recently announced on May 17^th 2018, stopping the screening, randomization and dosing of BACE inhibitor, atabecestat in the Phase 2b/3 EARLY study in late-onset preclinical stage Alzheimer’s disease and in a Phase 2 long-term safety study. With this announcement, Janssen has entered the long list of companies with their drugs having failed trials or outcomes in Alzheimer’s disease.

The company commented that, 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 been studying an investigational drug called a BACE inhibitor. The goal of this research is to slow cognitive decline in people at risk for Alzheimer’s dementia. Elevations of liver enzymes, which were serious in nature, have been observed in some study participants who received the Janssen BACE inhibitor, atabecestat. After a thorough evaluation of all available liver safety data from our studies, Janssen has concluded that the benefit-risk ratio is no longer favorable to continue development of atabecestat for people who have late-onset preclinical stage Alzheimer’s disease.

The company further underlined that the clinical trial investigators, study participants, health authorities, ethics committees, and institutional review boards are being informed about this matter. The company also assured that all participants in both studies will be offered safety and efficacy evaluations and the study protocol would be updated for longer-term follow up of participants who received atabecestat after they discontinue treatment. More than 600 people have received the study drug or placebo in the clinical trials.

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News Source: http://www.janssen.com/neuroscience/update-janssens-bace-inhibitor-program

Image Source: https://www.genengnews.com/the-lists/unlucky-13-top-clinical-trial-failures-of-2016/77900787