Promising Biogen Alzheimer's drug leapfrogs from phase I to phase III
- Biogen Idec has been testing a promising investigational treatment for Alzheimer's disease (AD) in phase I trials. After 54 weeks, AD patients treated with Biogen's therapy had significantly improved cognition and decreased evidence of amyloid plaque deposition.
- Based on the strength of these results, Biogen is planning to move directly from phase I testing to phase III testing, bypassing phase II altogether.
- Biogen's stock was up 8% on the news on Tuesday and opened up another 1% on Wednesday.
The quest for an effective treatment for AD continues as numerous companies research and develop investigational AD diagnostics and treatments. According to the Alzheimer's Association, approximately 5.4 million people in the U.S. have AD—a number that is expected to increase to a staggering 16 million by 2050 as the population ages and Alzheimer's diagnostics becomes more sophisitcated.
Total AD-associated costs in the America stand at $214 billion per year and expected to grow past the trillion-dollar mark in the next 35 years. Not only has there been no new treatment developed for AD since 1993—but available treatments only provide temporary respite from a relentlessly progressive disease process.
This is the backdrop against which Biogen has been developing its AD drug. The excitement surrounding its positive 54-week cognition data is further bolstered by reports of decreased amyloidosis—an important finding because it helps to validate the amyloid hypothesis of Alzheimer's. If phase III results are positive, it could signal the beginning of a new era in the treatment of AD. But given the history of disappointments in this therapeutic field, that is a big, big "if."
- Market Watch Biogen Alzheimer’s drug skips to Phase 3 testing