Merck confirmed today that it will not pursue its EPOCH study, one of its two late-stage trials associated with its promising Alzheimer’s drug Verubecestat.
The EPOCH study was evaluating the efficiency of the drug in patients with mild-to-moderate Alzheimer’s disease. Merck decided to halt the trials after an external Data Monitoring Committee, which assessed the overall risk and benefit of the drug, determined that there was “virtually no chance of finding a positive clinical effect”.
On a positive note, the company continues unchanged its APECS study, which evaluates Verubecestat in people with prodromal Alzheimer’s diseas. Results for this study are expected in February 2019 according to the company.
Verubecestat is a BACE1 inhibitor, who could theoricaly prevent the production of amyloid-beta proteins by blocking the internal activity of this protein.
The amyloid-beta proteins are among the leading suspects when it comes to Alzheimer’s disease. They form plaques in the brains of Alzheimer’s patients, and are thought to trigger the disease, although this hypothesis has yet to be confirmed.
The drug was used in a phase I clinical trial in 2012 involving 32 patients living with mild to moderate Alzheimer’s disease. The results of that study were recently published in Science Translational Medicine.
According to the authors, once-daily doses of Verubecestat for one week reduced up to 84 % of the levels of amyloid-beta peptide production in the cerebral spinal fluid.
The APECS phase III study will evaluate whether this biological effect translates into slowing the development of Alzheimer’s disease.