- Later this year, Biogen is launching two large Alzheimer's disease (AD) studies focused on the effect of its promising (if controversial) BIIB037 on early-stage AD patients.
- The two studies will each run for 18 months and include roughly 1,350 patients.
- The goal is to replicate the success of the phase I studies on a much larger scale, and to determine more safety data.
As Biogen finalizes trial design in order to initiate recruitment, the excitement continues to grow for BIIB037, which could make history as the first drug to actually treat early AD, instead of simply treating symptoms while the disease progresses.
Phase I results were compelling not only because use of BIIB037 resulted in decreased levels of amyloid plague in the brains of affected patients, but also because these decreases correlated with improved cognition. Improving cognition in patients with mild cognitive impairment (MCI)—early-stage AD, or AD that has progressed beyond the earliest stage—is the holy grail of AD treatment. However, it should be noted that patients in the phase I trial who possessed a gene making them particularly susceptible to AD experienced a concerning level of brain swelling at the highest, and most effective, dose of the investigational compound.
As it moves into phase III, Biogen is mindful of previous failures of high-profile contenders in the AD therapeutics race, including Eli Lilly, Pfizer, and Johnson & Johnson. One strategy the company is using is focusing on multiple targets beyond amyloid, including tau and BACE proteins. The chances for Biogen are as good as they've ever been for any company—and potentially better, because Biogen is benefiting from the years of research that has led us to this point.