Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek’s own, and he does not in any way speak for his employer.
I mentioned last year that Merck’s BACE inhibitor trial for Alzheimer’s had been stopped for futility. Now here’s the full writeup in NEJM, and futility appears to have been le mot juste. There were two treatment groups (12 mg and 40 mg), and in neither one did the ADAS-cog or ADAS-ADL scores (scales for degree… Read More
Here are some sequels to stories I’ve written about here, things that have had some new chapters added to them. First off, this 2015 post mentions the steep drop in shares of Clovis Biotechnology, brought on by a rather sudden revision in the announced clinical performance of their lead drug (the covalent kinase inhibitor rociletinib). Well… Read More
Man, Alzheimer’s. That’s my reaction to yesterday’s news in the field. Merck started things off with news of their last-ditch attempt to see if their beta-secretase (BACE) inhibitor verubecestat (MK-8931) could be useful. I’ve been writing about that one for a while – here’s 2012, when they announced that the com… Read More
Politico is a good source for national political stories, but I don’t usually look to them for coverage of drug development. But they’ve done a good job with their recent “Pharma Issue”. One of the stories (by David Freedman) is on the difficulties of Alzheimer’s drug discovery, which are legendary. The contrast betwe… Read More
Yesterday was not a good day for small companies trying to get drugs to regulatory approval for tough diseases. You may well remember Axovant, a company that I’ve written about several times (most recently here). To recap, AXON was started by a fund manager, who bought a failed Alzheimer’s candidate off GSK, announced that they’d… Read More
Failure after failure has been the story on amyloid-targeting therapies in Alzheimer’s. Tau protein, which is involved in pathology of its own in the disease, has been less in the spotlight (although TauRx has done its part by missing its clinical endpoints with its own drug). But there’s a lot of activity going on with… Read More
This exact point came up around here when we last discussed FDA reform, so it’s good to see it made at length in the New England Journal of Medicine. Remember solanezumab? That was the amyloid-targeting antibody that Eli Lilly kept on investigating in trial after trial, looking for some effect on Alzheimer’s. Last November, the final… Read More
There was some Alzheimer’s news the other day, but it wasn’t actually about Alzheimer’s. Not very much. It was more about hype, press releases, and a grievous lack of understanding of statistics. Via @AndyBiotech and @biotechtoreador on Twitter, I came across this release about an announcement from a small company called Neurot… Read More
Yes indeed, Merck announced last night that the first Phase III trial of their beta-secretase (BACE) inhibitor verubecestat was stopped because of futility. The monitoring committee, after looking over the data so far (the trial’s been running since 2012) concluded that there was no real chance of seeing efficacy. Merck had been enrolling pa… Read More
The news from Eli Lilly is not good – they’re laying off 485 people, according to filings with the state, and it appears to be completely a result of their latest Alzheimer’s clinical failures. The positions are largely in the company’s sales and marketing area. According to that article from FiercePharma, the company had be… Read More
