(MDVN - Get Report)
Alzheimer's drug, Dimebon, failed an important phase III study, the company announced today.
Sigh. Welcome to a depressing, bonus
Biotech Stock Mailbag
where I will take my lumps and try to dissect some lessons learned.
I wrote an account of the
failed Dimebon study
Via Twitter, @xietrank writes, "
U go 2 hell.
Along those same lines, Stan P. emails, "
Nice job, chump. How do you feel now?
I feel bad. I feel disappointed. I was never a table-thumping Medivation bull when it came to the Dimebon study results in Alzheimer's, but I did give the
study a 60:40 chance of being successful
. Clearly, I was very, very wrong on that count. My apologies all around.
@bobbandera tweets, "
Can't trust clinical trials in Russia. Phase II was done there.
Yes. One of the big lessons from this carnage is that investors should think twice (three, four or five times, perhaps) before believing phase II data generated from studies conducted in Russia -- or from Eastern Europe for that matter.
Recall that the phase II Dimebon study was conducted in Russia and was amazingly positive. Too positive, it turns out now, since it's clear those results were an outlier at best, or, at worst, were somehow mis-interpreted or even manufactured.
In this case, the Russian data were heavily scrutinized, picked over, audited and even published in the
, a well-respected medical journal. None of that mattered.
If you're keeping score,
(CTIC - Get Report)
have all fallen prey to the "Russian data" sinkhole. The only company I can think of that succeeded with a phase III study conducted almost entirely in Russia was
and its breast cancer drug Abraxane.
Tom M. emails, "
The Dimebon result is a clear negative, but is there anything positive to salvage from the study? What happens to the other Dimebon studies in Alzheimer's?
Medivation disclosed more data in Wednesday's press release than I expected, not much of it promising. It seems clear that Dimebon didn't provide any benefit at all compared to placebo when patients were measured by ADAS-cog and CIBIC-plus, the two most important cognitive and memory scales used in Alzheimer's studies.
The placebo patients did remain essentially stable through the six months of the study, which is a bit of a surprise given their relatively poor cognitive function at baseline. When I previewed the phase III study, I said one of the keys to success would be getting patients in the phase III -- both those treated with Dimebon and placebo -- to behave like they did in the phase II study.