Merck (NYSE: MRK), known as MSD outside the United States and Canada, today confirmed the completion of enrollment for the EPOCH trial, a Phase 2/3 randomized, placebo-controlled, parallel-group, double-blind study of verubecestat, formerly known as MK-8931, the company’s investigational oral small molecule selective beta secretase (BACE1) inhibitor, in patients with mild-to-moderate Alzheimer’s disease (AD). The ongoing study commenced in November 2012, completed enrollment in the fourth quarter of 2015 and is estimated to reach primary trial completion in July 2017.
“Alzheimer’s disease is a devastating disease for which there are limited available treatments,” said Dr. David Michelson, vice president clinical research, neuroscience, Merck Research Laboratories. “This is an important milestone as we evaluate the efficacy and safety of verubecestat, and understand its potential to help address the significant unmet medical need in this progressive and debilitating disease.”
For more than 10 years, Merck has been researching ways to treat AD across the continuum of the disease—investigating ways to modify disease progression and improve management of symptoms in later stages.
The ongoing EPOCH study is designed to evaluate the safety and efficacy of two oral doses of verubecestat (12 mg and 40 mg) administered once daily versus placebo in patients with mild-to-moderate AD currently using standard of care treatment. The primary efficacy outcomes of the study are the change from baseline in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score, as well as the change from baseline in the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score, following 78 weeks of treatment.
Merck is also investigating the safety and efficacy of verubecestat in the earlier, prodromal phase of AD in an additional Phase 3 clinical trial called APECS.