Merck is set to suspend a Phase III trial for APECS, evaluating verubecestat (MK-8931) in people with prodromal Alzheimer’s disease (AD).
The decision is based on a recommendation by the external Data Monitoring Committee (EDMC ), which examined the overall benefit/risk of verubecestat during a recent interim safety analysis.
eDMC has suggested that the trial might not have been able to establish any positive benefit/risk.
Merck Research Laboratories president Dr Roger Perlmutter said: “We are disappointed with this outcome, especially given the lack of treatment options for patients suffering from Alzheimer’s disease.
“We are grateful to the patients and caregivers who participated in this study, and despite this outcome, Merck remains committed to developing novel therapies for the treatment of Alzheimer’s and other neurodegenerative diseases.”
APECS is a randomised, placebo-controlled, parallel-group, double-blind trial, which is designed to assess the efficacy and safety of verubecestat in prodromal AD patients.
Verubecestat is an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1).
As part of the trial, the enrolled patients have been randomised to receive placebo, or 12mg or 40mg of verubecestat once-daily.
The trial’s primary efficacy object is change from baseline in the clinical dementia rating scale-sum of boxes (CDR-SB) score following 104 weeks of treatment.
Last month, Merckreported positive data from a Phase II trial investigating KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), who were previously treated with systemic therapy (sorafenib).