FDA fast-track status for Alzheimer's candidate E2609

The US Food and Drug Administration has granted Fast Track designation for the development of the beta secretase cleaving enzyme (BACE) inhibitor E2609 which was discovered by Japan’s Eisai (TYO: 4523) and is being jointly developed with US biotech major Biogen (Nasdaq: BIIB).

E2609 is currently being investigated in Phase III clinical studies for early Alzheimer's disease. The companies are also co-developing Eisai's other investigational Alzheimer's disease treatment, BAN2401, an anti-Aβ protofibril antibody, in major markets, such as the USA, the European Union and Japan.

Discovered in-house by Eisai, E2609 is an investigational next-generation oral candidate for the treatment of Alzheimer's disease that is believed to inhibit BACE, a key enzyme in the production of amyloid beta (Aβ). 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 MISSION AD began in October 2016 and will enroll 1,330 patients with biomarkers confirmed for early Alzheimer's disease.