Janssen Halts Clinical Development of Alzheimer’s Candidate Atabecestat Due to Liver Issues

Janssen Halts Clinical Development of Alzheimer’s Candidate Atabecestat Due to Liver Issues
Janssen pulled the plug on a Phase 2b/3 trial and a Phase 2 safety study of its Alzheimer’s disease experimental therapy atabecestat due to toxicity issues as a result of serious elevations in liver enzymes seen in some study participants. Atabecestat is a BACE inhibitor, intended to slow cognitive impairment. This enzyme mediates the production of beta-amyloid, which is the key component of senile plaques in the brain, and triggers cellular processes that lead to nerve cell death in Alzheimer’s disease. After reviewing all available liver safety data, the company concluded that the benefit-risk ratio for the development of atabecestat is no longer favorable. This led Janssen to halt the screening, randomization of participants into experimental groups, and dosing in both the Phase 2b/3 EARLY trial (NCT02569398) in late-onset preclinical (asymptomatic) Alzheimer's and in a Phase 2 long-term safety and tolerability study (2014-004274-41). Over 600 subjects received atabecestat or placebo in these studies. EARLY was a multi-center, double-blind trial of atabecestat (JNJ-54861911) in participants ages 60-85 and at risk for Alzheimer’s dementia. It aimed to evaluate whether the potential therapy slows cognitive decline compared to placebo in people who tested positive for amyloid. Janssen is now informing the clinical trials’ scientists, participants, health authorities, e
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