Now Enrolling: Global Phase 3 Clinical Study to Evaluate Eisai's BACE Inhibitor in Early Alzheimer's Disease

News provided by

Oct 31, 2016, 08:05 ET

WOODCLIFF LAKE, N.J., Oct. 31, 2016 /PRNewswire/ -- Eisai Inc. announced today that enrollment has begun in the U.S. for MISSIONAD, a Phase 3 clinical program for E2609, a Beta-secretase Cleaving Enzyme (BACE) inhibitor for patients with early Alzheimer's disease. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen as a potential Alzheimer's disease (AD) modifying treatment.

The first study, entitled MISSIONAD1, is a global, multicenter, placebo-controlled, double-blind, parallel-group clinical study which aims to assess the efficacy and safety of E2609 in 1,330 patients with biomarkers confirmed for early Alzheimer's disease. The treatment group will be administered a dosage of 50 mg of E2609 daily during the treatment period of 24 months, and the primary endpoint will utilize the Clinical Dementia Rating Sum of Boxes (CDR-SB).

Discovered in-house by Eisai, E2609 is an investigational next-generation oral candidate for the treatment of AD that inhibits BACE, a key enzyme in the production of amyloid beta (Aβ) peptides. By inhibiting BACE, E2609 may decrease the formation of toxic Aβ peptide aggregates and amyloid plaques in the brain, thereby potentially slowing disease progression.

"We are committed to helping those with Alzheimer's through the continued development of clinical studies with our BACE inhibitor targeting the production of anti-amyloid beta proteins," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "Through the initiation of MissionAD1 and similar clinical trials, we hope to demonstrate the value of this compound for those who suffer from early Alzheimer's disease."

This release discusses an investigational agent in development and is not intended to convey conclusions about efficacy and safety. There is no guarantee that this investigational agent will successfully complete clinical development or gain FDA approval.

For more information about this trial, please contact Eisai Medical Information at 1-888-274-2378.

About the Collaboration Agreement between Eisai and Biogen

Based on the collaboration agreement, Eisai and Biogen will co-develop and, if approved, co-promote Eisai's investigational next generation AD treatment candidates E2609, a BACE inhibitor, and BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, in major markets, such as the United States, the European Union and Japan. Both companies will share overall costs, including research and development expenses. Eisai will book all sales for E2609 and BAN2401 following marketing approval and launch, and profits will be shared between the companies. Also, Eisai has received from Biogen an additional one-time payment as well as the right to receive additional development milestone payments. Under the same agreement, Eisai also holds options to jointly develop and commercialize two of Biogen's candidates for Alzheimer's disease, the anti- Aβ antibody aducanumab and an anti-tau antibody.

About Eisai Inc.

As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we are a fully integrated pharmaceutical business with discovery, clinical, and marketing capabilities. Our key areas of focus include oncology and neurology (dementia-related diseases and neurodegenerative diseases). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based pharmaceutical company that discovers, develops and markets products worldwide. Guided by its corporate mission of "giving first thought to patients and their families, and to increasing the benefits that health care provides," all Eisai employees aspire to meet the various needs of global health care as representatives of a "human health care (hhc) company" that is capable of making a meaningful contribution under any healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com/.