Alzheimer Drug Fails Trial
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For a drug expected to top $7B in annual sales, even a partial success looks like a failure to me. I’ve talked about the efficacy in modulating APP for the treatment of Alzheimer’s a few times and Derek Lowe @ has some great articles, so if you’re not familiar, I‘d check them out to catch up.
On to the news. I’m going to try and summarize the press release from Elan and Wyeth without all the spin. Bapineuzumab failed to reach significance on the primary endpoint in a phase 2 trial.
Simple, right? Maybe not. The trial did show efficacy, though magnitude wasn’t released, in a small subgroup of patients (in non-carriers of the ApoE4 allele, estimated to be ~40% of Alzheimer’s patients).
So, right off the bat, this should cut analyst expectations by 60% right?
Interestingly, in trying to explain away not hitting the primary endpoint for the general population, the release mentions that the study wasn’t powered to detect changes in ADAS-cog.
Fantastic. Let me just break down this flow and see if we can make more sense of it.
1.) Run a trial that is not powered to detect primary endpoint changes.
2.) Fail primary, ADAS-cog endpoint.
3.) Release that you succeeded in a subgroup of patients on many endpoints (that you admittedly aren’t powered to detect)
4.) Conclude with statements like, “bapineuzumab appeared to have clinical activity in treating Alzheimer’s disease“, and “…the Phase 2 study are a continued validation of the amyloid approach to Alzheimer’s disease”.
Fundamentally, I’m happy that there are companies with deep-pockets attempting to treat debilitating diseases in novel ways but doing things over and over, expecting different results is foolish.
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This article has 9 comments:
What about Perispinal Etanercept? Why wasn't this studied since the results of the Phase I clinical trial showed actual improvements in Cognitive Ability and has maintained the progression of the disease in some patients for over 3 years? Somebody needs to get on this!
neurologist
What medical/scientific qualifications do you possess that allow you to reach such outrageously false and biased statements? Yesterdays news from Elan was a HUGE step forward for Alzheimer treatment. I am convinced that the FDA will now be forced to make the PIII open label for the Non-ApoE4 carriers. In the end, your poorly informed commentary will emerge as the only thing foolish associated with these results.
Nice pic....you may want to rethink that. You look like the Village Idiot.
Your picture matches your journalistic skills.
r
r
I can't believe I took this guy seriously after reading his article. Take a look at this blog. Put bluntly, this guy is a typical raving internet hack who appears to be trapped in the "blogosphere"...
I wish you luck in your future pursuits.
If, when the results are published in July and after the first phase III data is in, I am wrong, I'll be the first to admit it (I doubt you'll be offering me the same consideration and dropping me emails if I'm right).
Until then, my opinion remains that no program targeting amyloid-beta or the pathway has shown efficacy on the primary (read: approvable) endpoint of ADAS-cog.
I hope I'm wrong. I hope targeting the amyloid-beta pathway leads to truly disease modifying therapy but believing doesn't make it true.