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BACE Inhibitor Receives FDA Fast-Track Designation for Early Alzheimer's Disease

Phase 3 clinical trial of investigational agent began in October 2016

The FDA has granted a fast-track designation to Eisai, Inc., for the development of E2609, a beta-secretase cleaving enzyme (BACE) inhibitor currently being evaluated in phase 3 clinical trials for early Alzheimer's disease (AD). E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen as a potential 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 the FDA. It may also enable priority review by the FDA if supported by clinical data at the time of new drug application submission.

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 (AB) peptides. By inhibiting BACE, E2609 may decrease the formation of toxic AB peptide aggregates and amyloid plaques in the brain, thereby potentially slowing disease progression. The first phase 3 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.

Based on a collaboration agreement, Eisai and Biogen will codevelop and, if approved, copromote Eisai's investigational next-generation AD treatment candidates E2609 and BAN2401, an anti-AB protofibril antibody, in major markets. Eisai also holds options to jointly develop and commercialize two of Biogen's candidates for Alzheimer's disease, the anti-AB antibody aducanumab and an anti-tau antibody.

E2609 is an investigational agent in development; there is no guarantee that it will successfully complete clinical development or gain FDA approval.

Source: Eisai, Inc.; November 17, 2016.

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