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August 7, 2012
Bapineuzumab Still Does Not Work Against Alzheimer's
As expected (by all but the most relentlessly optimistic observers), the anti-Alzheimers antibody bapineuzumab has now failed in its most likely patient population. Results came out last night about from patients who do not carry the ApoE4 mutation, the only group that seemed to offer hope in earlier clinical trials. The therapy missed its endpoints versus placebo, and according to Pharmalot, subgroup analysis offered no hope that there was some further fraction of patients that might be responding. (You would have had to have been a pretty hardy investor to carry on even if something had shown up).
But apparently Pfizer and J&J are those hardy investors, because (as that link shows), they're apparently going on with an already-in-progress Phase II study of the antibody dosed subcutaneously. That baffles me - I don't know enough about antibody dosing to say if that makes a difference, but it seems odd to think that it would. And clinical work on another active immunization therapy is going on as well (as opposed to dosing a pre-made antibody).
Good luck to them on that - I mean that sincerely, because the Alzheimer's field needs any successes it can find. The immunological approach has been a long and hard one, and hasn't delivered much encouragement so far. But on the other hand, it's immunology, which means that it's still a wild black box in many ways and capable of all kinds of unexpected results. But that said, it's still hard to imagine that Eli Lilly's competing antibody solanezumab has much chance of working, at this point. We'll hear about that one soon, and I very much expect to be using the phrase "missed endpoints" again. I might be using the phrase "subgroup analysis", though, in which case the phrase "more money" will also make an appearance.
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