Eisai Co. Ltd.'s investigational Alzheimer's drug, elenbecestat, demonstrated safety and tolerability in patients at a higher dose, the Japan-based drugmaker said in a press release.
The 70 patients participating in a mid-stage clinical trial known as Study 202 have been diagnosed with either mild cognitive impairment or mild to moderate dementia, both due to Alzheimer's disease.
They were confirmed to have a buildup of amyloid beta, abnormal proteins that accumulate in the brain in Alzheimer's that are thought to contribute to the development of the disease.
The 18-month long phase 2 trial randomized the patients to receive either placebo or elenbecestat at 5 milligrams, 15 milligrams or 50 milligrams on a daily basis.
During the trial, more than half of the patients who were receiving elenbecestat at the lower doses switched to 50 milligrams for at least three months.
Patients who received 50 milligrams were treated for a mean duration of 11 months during the 18-month long study, demonstrating acceptable safety and tolerability profile with no serious adverse events.
Discovered by Eisai, elenbecestat is a beta amyloid cleaving enzyme — or BACE — inhibitor. It works by blocking the action of BACE, which is important for the production of amyloid beta proteins.
It has been co-developed by Eisai and Cambridge, Mass.-based drug developer Biogen Inc. since 2014 and is being studied in two late-stage trials for treating early Alzheimer's.
