OK, we have some Alzheimer’s data to talk about this morning. Biogen’s antibody aducanumab, about which people have been wildly enthusiastic, showed very little effect on mental decline at a 6mg dose, the company reported today. Note that the Phase I data that got all the attention was at 3mg and 10mg (with better results at the higher dose), but that the 3mg dose was still positive.
That, though, was a smaller and less powered trial. And the first thing that has to be learned from watching clinical research (especially for a disease like Alzheimer’s) is that you cannot draw conclusions until you see a large, well-run data set. Ignore this advice at your peril. The list of promising-looking Alzheimer’s ideas that have evaporated on contact with a larger trial is long and terrible.
What’s interesting is that aducanumab did seem to show the expected reduction in amyloid, which makes a person wonder (yet again) what it takes to draw that connection, assuming that it can be drawn. Biogen’s getting ready to go into a big Phase III (2700 patients), and that, of course, is where we’ll see what’s actually going on. If anything.
Meanwhile, Eli Lilly has released more data from the extended trial of their own antibody, solanezumab. That one’s gotten a lot of attention over the last few years as well (especially recently), as the company continues to develop it in the face of not-all-that-compelling clinical results. And by gosh, today’s data are. . .not all that compelling. The company claims that they’re seeing more effect in the patients who started the therapy earlier, but (as that link from Adam Feuerstein shows), not everyone is buying that interpretation. The effect they’re seeing may well be clinically meaningless.
Lilly is already going on with another Phase III in mild, early Alzheimer’s patients, chasing what they see as a real result and trying to make the most of it. With one hand, I cheer them on – Alzheimer’s is an awful disease, we can’t do a damn thing for it, and a new therapy is desperately needed. It’s actually sort of inspiring to see a company put so much money on the line in an attempt to do something about it. But with the other had, I’m wiping my brow as I shake my head. I’ve never been able to convince myself that solanezumab is much good. I think that marginal Alzheimer’s drugs are far, far more likely to flop than they are to hang on and become the first-in-class that companies dream of. And I wish that weren’t so.