Eisai Presents Data on BACE Inhibitor Elenbecestat (E2609) at 9th Clinical Trials on Alzheimer's Disease (CTAD) Meeting

News provided by

Dec 12, 2016, 08:06 ET

WOODCLIFF LAKE, N.J., Dec. 12, 2016 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today the presentation of two posters highlighting the latest data on elenbecestat (development code: E2609), its in-house discovered Beta Amyloid Cleaving Enzyme (BACE) inhibitor. The posters were presented at the 9th Clinical Trials on Alzheimer's Disease (CTAD) meeting in San Diego, California.

The first presentation (poster presentation number: P3-28) highlighted the results from an integrated analysis of pharmacokinetic and pharmacodynamics data from a Phase 2 clinical study (Study 202) of elenbecestat in patients who had confirmed positive levels of brain amyloid based upon PET screening and clinically staged with mild cognitive impairment (MCI) due to Alzheimer's disease or mild-to-moderate dementia due to Alzheimer's disease, as well as a Phase 1 clinical study of elenbecestat in healthy individuals. Study 202 is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety of elenbecestat and the change from baseline in cerebrospinal fluid (CSF) amyloid beta Aβ(1-x)* level. Patients are administered 5, 15 or 50 mg of elenbecestat daily and the change in Aβ1-x level is measured by the concentration of Aβ1-x in plasma and CSF before and after elenbecestat administration.

From the results of the integrated analysis of the studies, a decrease in CSF Aβ1-x in response to the plasma concentration of elenbecestat was observed in patients who were administered elenbecestat, which was similar to the prior findings from Phase 1 studies in healthy individuals. Overall, the relationship between plasma concentration of elenbecestat and Aβ1-x levels was similar in healthy individuals and patients with MCI due to Alzheimer's disease or mild-to-moderate Alzheimer's disease dementia.

The second presentation (poster presentation number: P3-27) highlighted the results from a bridging study of elenbecestat to investigate whether or not there is a difference in the pharmacokinetics and pharmacodynamics between Japanese and white populations. The study was conducted as a Phase 1 randomized, double-blind, placebo-controlled study investigating the pharmacokinetics and pharmacodynamics of a single oral dose of 5, 50 or 200 mg of elenbecestat in healthy adult Japanese subjects and 50 mg of elenbecestat in white subjects.

From the results of the study, a dose-dependent decrease in plasma Aβ1-x level was observed in Japanese subjects. Furthermore, pharmacokinetic and pharmacodynamic parameters were similar between Japanese and white subjects. Safety findings were similar between Japanese and white subjects.

For global Phase 3 clinical studies (known as MISSIONAD), the dosage of elenbecestat is 50 mg.

"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," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer of the Eisai Neurology Business Group. "As a company, we are committed to developing elenbecestat and other new medicines to address the total care of patients with this devastating illness."

Discovered in-house by Eisai, elenbecestat is an investigational oral Beta Amyloid Cleaving Enzyme (BACE) inhibitor under development for Alzheimer's disease. By inhibiting BACE, a key enzyme in the production of Aβ peptides, elenbecestat decreases the formation of these peptides which can aggregate into toxic oligomers and protofibrils and eventually form amyloid plaques in the brain. It is believed that decreasing the formation of these plaques may potentially slow disease progression.

Elenbecestat is being jointly developed by Eisai and Biogen Inc. and is currently being investigated in a global Phase 3 clinical study (known as MISSIONAD1) as a potential treatment for early Alzheimer's disease. In addition, the U.S. Food and Drug Administration recently granted Fast Track designation for the development of elenbecestat.

Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thought to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Co. Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including oncology and neurology. For more information about Eisai Co., Ltd., please visit www.eisai.com.

* Aβ1-x refers to Aβ peptides of all lengths