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March 3, 2010
Dimebon Comes Crashing to Earth
Earlier this month I wrote about Medivation and their Russian-derived clinical candidate for Alzheimer's disease, Dimebon (latrepirdine). At the time, I wrote that "A lot of eye-catching numbers from small Phase II trials tend to flatten out in the wider world of Phase III, and if forced, that's the way I'd bet here."
Unfortunately, that's just what appears to have happened. The results are out today, and Dimebon has not showed any efficacy at all versus placebo. From the data given in the press release, the comparison is just absolutely flat; you could have been giving the study patients breath mints and seen the same numbers. Since the design of this trial was similar to the smaller Phase II trials that showed such interesting results, there's clearly something going on that we don't understand. But that's the motto for all central nervous system research, isn't it?
I'm really not sure if there's a way forward for this drug. When you go to a larger, more well-controlled trial and revert back to baseline, it's hard to make a case for continued development. Pfizer (Medivation's partner here) still has a lot of money and a lot of desire to find a good Alzheimer's drug. But I don't think they'll be in the mood to spend much more of it here.
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