Enough data to take Eisai and Biogen's Alzheimer's drug into Phase III

The US Food and Drug Administration (FDA) has given the nod for Japanese pharma major Eisai (TYO: 4523) and US biotech Biogen (Nasdaq: BIIB) to take their investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 into Phase III studies in Alzheimer’s.

E2609 was discovered by Eisai and is being jointly developed by that company and Biogen for early Alzheimer's disease. By inhibiting BACE, it decreases Aβ proteins in the brain, potentially improving symptoms and slowing disease progression.

At a meeting at the end of Phase II studies, the FDA confirmed that the data package was sufficient to commence Phase III trials, which have proved notoriously difficult for developers of Alzheimer’s treatments to overcome.