Biogen, Eisai Start New Phase 3 Trial For Pre-clinical Alzheimer’s Disease


Biogen (BIIB), in collaboration with Eisai, and the Alzheimer’s Clinical Trials Consortium, has initiated a new global Phase 3 clinical study (AHEAD 3-45) with BAN2401, an anti-amyloid beta (Aβ) protofibril antibody.

The study will evaluate the therapeutic effect of BAN2401 on the progression of Alzheimer’s disease in individuals in preclinical (asymptomatic) stages of the disease. These patients are clinically normal and have intermediate or elevated levels of amyloid in their brains.

The AHEAD 3-45 program consists of two trials, A3 and A45, which aim to evaluate the potential of BAN2401 to reduce accumulation of harmful amyloid beta aggregates in the brain and prevent cognitive decline due to Alzheimer’s disease.

A total of 1400 participants will be enrolled in the study, and will be conducted in the US, Canada, Japan, Australia, Singapore and Europe.

The A3 trial will enroll participants with an intermediate amount of amyloid in the brain and high risk for further amyloid beta accumulation, and thus at risk for developing clinical symptoms of Alzheimer’s disease. The aim is to evaluate the potential of BAN2401 to stop or reduce aggregation of harmful amyloid beta in the brain before any clinical symptoms develop.

The A45 trial will enroll participants with elevated levels of amyloid beta in the brain. The trial will measure the effect of BAN2401 in preventing cognitive decline and suppressing progression of Alzheimer’s disease pathology in the brain.

“A successful outcome would provide opportunities to treat patients at a very early stage, or even preventing the disease, thereby substantially reducing patients’ suffering and providing substantial cost savings for society at large,” commented Gunilla Osswald, CEO, of Eisai’s business partner, BioArctic AB.

Shares in Biogen are down 6% year-to-date, and analysts have a cautious Hold consensus on the stock. That’s with 8 recent buy ratings, vs 13 holds and 4 sells. Meanwhile the average analyst price target stands at $309 (12% upside potential). (See BIIB stock analysis on TipRanks)

On July 8 Biogen announced that it had completed its biologics license application (BLA) regulatory submission for aducanumab, an investigational human monoclonal antibody for Alzheimer’s disease- and requested priority review. The US regulatory body, the FDA, now has 60 days to accept the filing, which will kick off a review of the application.

JP Morgan’s Cory Kasimov anticipates that BIIB will receive Priority Review given the unmet medical need and expects the FDA to hold an Advisory Committee to get experts to weigh in on the package; this would likely occur in 2H20 under a priority review.

“That said, this does not change our view on the candidate’s approval prospects, which we currently see as little better than a coin flip” the analyst wrote, adding that “with mounting pressures to the core franchises lowering BIIB’s perceived floor valuation, everything appears to be riding on this single, controversial asset.” As a result he reiterated a Hold rating on Biogen.

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