Merck stops EPOCH study into Alzheimer's drug
Citing a lack of efficacy, Merck has halted protocol 017, also known as the EPOCH study, an evaluation of the Alzheimer’s disease drug verubecestat, according to a press release.
The company stated that the stoppage comes after the external Data Monitoring Committee, determined during an interim safety analysis that there was “virtually no chance of a positive clinical effect”. The decision to stop the study was based solely on efficacy, not safety, as the committee noted that the safety signals observed “are not sufficient to warrant stopping study 017.”
According to the release, verubecestat is an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 in patients with mild-to-moderate Alzheimer’s disease.
The EPOCH study is a Phase 2/3 parallel-group, placebo-controlled, randomized, double-blind trial evaluating the efficacy and safety of two oral doses of 12 mg and 40 mg per day vs. placebo in patients with mild-to-moderate Alzheimer’s disease currently using standard of care treatment. Primary efficacy outcomes are the change from baseline in the Alzheimer's Disease Assessment Scale Cognitive Subscale score and the Alzheimer's Disease Cooperative Study–Activities of Daily Living score following 78 weeks of treatment. EPOCH’s results will be analyzed and presented at an upcoming scientific meeting, the company stated.
“Alzheimer’s disease is one of the most pressing and daunting medical issues of our time, with inherent, substantial challenges to developing an effective disease-modifying therapy for people with mild-to-moderate disease. Studies such as EPOCH are critical, and we are indebted to the patients in this study and their caregivers,” Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, said in the release. “While we are disappointed that a benefit was not observed in [the EPOCH] study, our work continues with APECS, which is studying verubecestat in people with less advanced disease.”
According to the release, APECS is a parallel-group, placebo-controlled, randomized, double-blind Phase 3 clinical trial evaluating the safety and efficacy of verubecestat in people with prodromal Alzheimer’s disease. Patients are randomly chosen to receive placebo, or 12 mg or 40 mg of verubecestat, once a day. The primary efficacy outcome of APECS is the change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes score following 2 years of treatment. Results from APECS are expected in 2 years.