Lilly has reported results from its anti-amyloid antibody, solanezumab, and. . .well, it’s mixed. And it’s either quite good news, or quite bad. You make the call.
The therapy missed its endpoints (both “cognitive and functional”, according to the company) in two clinical trials, so that’s clearly bad news. Progression of Alzheimer’s disease was not slowed. But I’ll let the company’s press release tell the tale from there:
The EXPEDITION1 study did not meet co-primary cognitive and functional endpoints in the overall mild-to-moderate patient population; however, pre-specified secondary subgroup analyses in patients with mild Alzheimer’s disease showed a statistically significant reduction in cognitive decline. Based on those results, Lilly modified the statistical analysis plan (SAP) for EXPEDITION2 prior to database lock to specify a single primary endpoint of cognition in the mild patient population. This revised primary endpoint did not achieve statistical significance.
Now, this news – what you’ve just read above – actually is sending Lilly’s stock up as I write this, which tells you how beaten-down Eli Lilly investors are, or how beaten-down investors in Alzheimer’s therapies are. Or both. The headlines are all about how the drug missed in these trials, but that the company sees some hope. But man, is it ever a faint one.
What I’m taking away from the company’s statement is that they had a cognition endpoint defined at the beginning of the trial (as well they should). We can assume that it was not a wildly optimistic one; no one is wildly optimistic in this field. And solanezumab missed it in the first Phase III data. But the patients with milder Alzheimer’s, when they looked more closely, showed a trend towards efficacy, so they modified the endpoints (that is, lowered the bar and narrowed down to a select population) in the data for the second Phase III before it finished up. And even then, the antibody missed. So what we have are trends, possible trends, but nothing that really gets to the level of statistical significance.
But note, they’re talking cognitive efficacy, and there’s nothing said about those functional endpoints. If I’m interpreting this right, that means that there was a trend towards efficacy in tests like remembering words and lists of numbers, but not a trend when it came to actually performing better in real-life circumstances. Am I seeing this correctly? Lilly will be presenting more data in October, and we’ll know more then. But I’m not getting an optimistic feeling from all this.
I assume that the company is now talking about going back and rounding up a population of the mildest Alzheimer’s patients it can find and giving solanezumab another shot. Given Lilly’s pipeline and situation, I suppose I’d do the same thing, but this is really a back-to-the-wall move. I think that you’d want to see something in a functional endpoint to really make a case for the drug, for one thing, and out in the real world, diagnosing Alzheimer’s that early is not so easy, as far as I know. Good luck to them, but they are really going to need it.