Two posters from Eisai were presented at the ninth Clinical Trials on Alzheimer’s Disease (CTAD), featuring the latest data on elenbecestat, Eisai’s Beta Amyloid Cleaving Enzyme (BACE) inhibitor.
The first of the two poster presentations focused on results from an integrated analysis of pharmacokinetic and pharmacodynamics data from a phase 2 clinical study of elenbecestat. Patients in this study had confirmed positive levels of brain amyloid after a PET screening and were clinically staged with mild cognitive impairment (MCI) from Alzheimer’s disease or mild-to-moderate dementia due to Alzheimer’s disease.
Results from phase one of a clinical study on elenbecestat in healthy people was also part of the first poster presentation. Results concluded that the relationship between plasma concentration of elenbecestat and A1-x levels was similar in healthy patients and patients with MCI, due to Alzheimers’s disease or mild-to-moderate Alzheimer’s disease dementia.
The results of a bridging study of elenbecestat -- to investigate a possible difference in the pharmacokinetics and pharmacodynamics between Japanese and white populations -- was the focus of poster presentation two.
In the phase 1 randomized, double-blind, placebo-controlled study, healthy Japanese patients were given a single oral dose of 5, 50, or 200mg of elenbecestat, and healthy white patients were given 50 mg. The noticeable results centered around a dose-dependent decrease of plasma A1-x levels in Japanese patients.
"We are pleased to present these data about elenbecestat, a compound with a targeted mechanism of action that has the potential to address the root cause of Alzheimer's disease," Dr. Lynn Kramer, chief clinical officer and chief medical officer at Eisai Neurology Business Group, said. "As a company, we are committed to developing elenbecestat and other new medicines to address the total care of patients with this devastating illness."
