Aducanumab RIP

You will recall from Beating the Dementia Monster that I auditioned for the Phase 3 trial for Aducanumab, but was rejected for failing to score low enough on their cognitive test.  This turned out to be a good thing, because, although the small Phase 1 trial showed promise, the Phase 2 trial results were not fulfilling that promise.  I had researched the history of the drug, and so I asked one of the researchers for the trial why they were going ahead with Phase 3.  He said it had a lot to do with funding.  The researcher doubted that the drug would fare better in the Phase 3 trial, and, well, he was right.

Aducanumab is a monoclonal antibody derived from the blood of elderly people free of AD.  The antibodies effectively "eat up" the amyloids in the brain.  

According to this week's ALZForum, Aducanumab has now been fully abandoned.  A futility analysis found that it just wasn't worth the effort of completing the Phase 3 trial.  The trial had engaged 3,200 participants from around the world to see what would happen if and when the drug actually removed amyloids from the brain.

This failure has produced profound disappointment in the research community, because huge hope had been placed on it.  There was an expectation that this was THE key to breaking the back of AD.  There has also now been a great deal of soul-searching, because (as I noted myself) there was strong early indication that the drug wasn't going anywhere.  So why was so much false hope created?  I know it created hope in me, because the buzz in 2015 was that an effective treatment would be available for me and people like me by 2019.  This looked like it.

Aside from the matter of how to approach the unwarranted creation of expectations, there is thought going into what the results mean for our understanding of AD.  The results reinforce recent thought that removing beta-amyloids after symptoms are evident is too late.  This is one imperative for finding a biomarker test, perhaps a blood test for amyloids, that will detect the onset of AD before symptoms first appear.

Also interesting is the performance of Biogen's stock price.  You will see here that it recently went into a tailspin, almost certainly due to this announcement.  (It fell by about 1/3 on March 21.) 

As a footnote, several authorities commented that it was not clear that Aducanumab actually removed amyloids from the brain.  Scan results may have been incorrectly interpreted to indicate that it did.