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July 22, 2015 no comments

New Data On Alzheimer’s Drug Candidates Changes Nothing

Sometimes data just speaks for itself. But more often, its left to scientists and journalists to try and draw useful conclusions from complex observations.  And so is the case with the latest data reported at the Alzheimer’s Association International Conference in Washington, D.C on two clinical-stage drug candidates.  Predictably, there has been no shortage of comment (for example, hereherehere).


The first thing to remember is that the degree of anticipation, even hype, surrounding these data has much more to do with the undoubted importance of Alzheimer’s Disease as an unsolved clinical and societal crisis in the making.  The data themselves were never going to make a difference, because one is a Phase 1/2 study and the other an extension study of a previously failed Phase 3.  Neither could ever have provided an unequivocal positive outcome.


So the chattering revolves around whether the new data makes a future pivotal Phase 3 with an anti-amyloid antibody more or less likely to be positive.  For bystanders, its fine to just wait and see since those trials are either running or have been committed to (although there is a very real risk that some of the coverage unreasonably raises hopes of helping current patients).  It is for investors, and other residents of the global “biotech village”, that divining some scant thread of meaning from such data becomes a life-or-death activity.


But how you interpret this data probably depends on your original starting position.


For those who felt the anti-amyloid drug candidates were “promising”, the new data is broadly seen as slightly disappointing, though by no means a knock-out blow (although, as I have already noted its unclear what, if anything, could every convince the most ardent acolytes of the “amyloid hypothesis” that these drugs could never work).  Judging by the decline in $BIIB share price (down 3-4% in immediate response to the data), many investors fell into this camp.

Ironically, for those who felt the previous extensive failures with anti-amyloid candidates in the clinic  had already sealed the coffin for this approach (and I have very publicly put myself in that camp), this data seems somewhat more encouraging.  For sure, the data have notched down expectations particularly for aducanumab (Biogen’s candidate), but the hype that surrounded the data released in March was entirely excessive given the size of the study set against the previous record of anti-amyloid agents in larger studies.  So a degree of disappointment was necessary and expected.


However, the bottom-line is that the new data strengthens the belief that the groups treated with anti-amyloid had slower …


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