The Alzheimer's Society has expressed its disappointment at Merck's decision to stop the EPOCH study, a phase 2/3 study evaluating Verubecestat in people with mild-to-moderate Alzheimer’s disease.
Merck’s announcement follows a recommendation from the external Data Monitoring Committee, which determined that there was “virtually no chance of finding a positive clinical effect" from the drug. The Committee assessed the overall risks and benefits of the drug during a recent interim safety analysis and noted that there were no safety concerns.
Verubecestat, an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), is thought to work by reducing the build-up of toxic amyloid plaques in the brain.
A second trial of the drug in people with prodromal (or pre-symptomatic) Alzheimer’s disease - APECS - will continue and results are expected in February 2019.
Dr Doug Brown, Director of Research at Alzheimer's Society, said: “It’s encouraging that there are no concerns over the safety of this drug and that it will continue to be tested in people in the pre-symptomatic stages of disease, where there is more chance that it will prevent the build-up of toxic amyloid plaques.
“However, we are disappointed that another trial has been stopped because the drug is failing to bring benefits for people with Alzheimer’s. It reiterates the importance of people receiving a dementia diagnosis as early as possible so that drugs have the best possible chance to stop or slow down damage to the brain.
“More than ever, we need to redouble our efforts to meet the G7’s ambition of finding a disease-modifying treatment for dementia by 2025. As we continue to hunt for a cure and new treatments, we must concentrate on finding the best ways to care for people living with dementia now."