Merck is halting the pivotal Phase II/III EPOCH trial evaluating its Alzheimer’s disease (AD) candidate verubecestat on the recommendation of the study’s external data monitoring committee (DMC). The DMC said that the trial had “virtually no chance of finding a positive clinical effect.” Following a recent interim safety analysis, the committee did, however, recommend that the second Phase III verubecestat clinical study APECS should continue. APECS is evaluating verubecestat therapy in people with prodromal AD. Data are expected in February 2019.
Verubecestat is a small-molecule inhibitor of the beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1). The placebo-controlled EPOCH study was investigating the efficacy of two doses of once-daily verubecestat, alongside standard of care in patients with mild-to-moderate AD. “While we are disappointed that a benefit was not observed in this study, our work continues with APECS, which is studying verubecestat in people with less advanced disease,” stated Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories.
Verubecestat’s failure in one of its two pivotal studies follows Eli Lilly’s disappointment in November 2016, when the firm’s monoclonal antibody AD candidate solanezumab bombed in its pivotal EXPEDITION3 study.