Their hope is that if that Phase II trial shows that beta-amyloid levels are reduced, they can claim this significantly differentiates it from the other AChEis, and that this should warrant fast track. They are building a circumstantial case--that Elan's vaccine reduced AB and improved cognition (setting aside the five fatalities for now)--hence if they can reduce AB, cognitive improvement should be likely. Unfortunately, they do not plan to run cognitive tests on the 75 pt AB level group, which is an unfortunate omission, and raises the question why they are skipping an obvious step (they said they werent powering the trial for cognitive change, but you would think that in a Phase II, even a trend would be pertinent to proof of principle).
It has always been difficult to pin down this company on key issues--for example, in June I asked them if it was true that they were wrestling with dose-limiting side effects in designing further trials, and was told that this was not true, and the dose had been selected, 20mg BID. Now they say they are 'finetuning' the dose.
Harry
NeuroInvestment |
