Eisai announced has received FDA Fast Track designation for the development of E2609, a Beta-secretase Cleaving Enzyme (BACE) inhibitor currently being evaluated in phase III clinical trials for 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 FDA's Fast Track program is intended to facilitate the development and review of new therapies to treat serious conditions and tackle key unmet medical needs by allowing for frequent interactions with FDA. It may also enable priority review by FDA if supported by clinical data at the time of NDA submission.
"We are excited that the FDA has granted Fast Track designation to E2609," said Lynn Kramer, M.D., chief clinical officer and chief medical officer, Neurology Business Group, Eisai. "We look forward to working closely with the FDA to expedite this clinical program and hope to offer an important treatment option for patients who suffer from early Alzheimer's disease."
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. The first phase III study for E2609 in the clinical trial program called MISSIONAD began in October 2016 and will enroll 1,330 patients with biomarkers confirmed for early Alzheimer's disease.
This release discusses an investigational agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that this investigational agent will successfully complete clinical development or gain FDA approval.