Studies Halted for Alzheimer's Candidate Atabecestat Due to Safety Concerns

Serious elevations of liver enzymes were noted among participants who received atabecestat
Serious elevations of liver enzymes were noted among participants who received atabecestat

Janssen announced that the Company will no longer continue studying atabecestat, an investigational treatment for asymptomatic patients at risk for developing Alzheimer's disease, after an evaluation of liver safety data indicated study participants who received the BACE (beta-secretase cleaving enzyme) inhibitor had developed elevated liver enzymes. 

After evaluating the safety data, the Company concluded that the benefit-risk ratio did not favor continuing with the development of the treatment. Screening, randomization, and dosing of atabecestat has been stopped in the Phase 2b/3 EARLY study in late-onset preclinical stage Alzheimer's disease and in a Phase 2 long-term safety study. 

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Janssen said in a statement that they are informing study participants (N>600), trial investigators, health authorities, ethics committees and institutional review boards about the situation. Participants in the studies will be offered safety and efficacy evaluations, with longer-term follow-up for those who received the study drug after they discontinue treatment.

For more information about these studies visit Clinicaltrials.gov or Janssen.com.