Merck & Co. terminates Phase III study of verubecestat in prodromal Alzheimer's disease

Merck & Co. on Tuesday said it was ending the Phase III APECS study of verubecestat, formerly known as MK-8931, for the treatment of prodromal Alzheimer's disease following a recommendation by an external Data Monitoring Committee. In its analysis, the committee concluded that the BACE1 inhibitor was unlikely to exhibit a positive benefit/risk ratio if the study continued. 

In the APECS study, patients were randomly assigned to once-daily treatment of verubecestat or placebo. The primary endpoint of the study was the change versus baseline in the Clinical Dementia Rating Scale-Sum of Boxes score after 104 weeks of treatment.  

Merck Research Laboratories president Roger Perlmutter remarked "we are disappointed with this outcome, especially given the lack of treatment options for patients suffering from Alzheimer's disease." The drugmaker noted that data from the trial will be presented at a future research conference. 

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Last year, Merck ended a Phase II/III study of verubecestat in the treatment of patients with mild-to-moderate Alzheimer's disease after an external data monitoring committee determined that there was little possibility that benefit would be observed. 

The most recent decision follows a number of high-profile failures in studies assessing experimental treatments for Alzheimer's disease. In 2016, Eli Lilly disclosed that the investigational treatment solanezumab failed to slow cognitive decline in patients with mild-to-moderate Alzheimer's disease. 

More recently, Axovant Sciences announced that experimental 5-HT6 receptor antagonist intepirdine missed its primary study endpoints in a trial of patients with mild-to-moderate Alzheimer's disease, with the company later ending development of the treatment. Meanwhile, Biogen and Eisai elected to continue a mid-stage study of the investigational anti-amyloid beta protofibril antibody BAN2401 despite the drug missing the primary endpoint of an interim analysis. 

For related analysis, read ViewPoints: Merck & Co. shelves verubecestat – is writing on wall for Biogen, Eli Lilly?

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