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It's baaaaack.....BAN2401
Posted: Friday, July 6, 2018 8:14 PM
Joined: 4/22/2017
Posts: 334

“This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis,” said Lynn Kramer, chief clinical officer and chief medical officer of Eisai’s neurology unit. “We will discuss these very encouraging results with regulatory authorities to determine the best path forward.”

Lane Simonian
Posted: Sunday, July 8, 2018 10:07 AM
Joined: 12/12/2011
Posts: 5027

Biogen is a company that seems to be manipulating data.  In its trial with Aducanumab, it released data on all its doses except the 6 mg dose.  Four months later it released the data for the 6 mg. dose which did not significantly effect the progression of the disease.  When did the company know this?

In the current Aducanumab trial, Biogen increased the trial size in the midst of the trial, because it apparently was not getting the results it wanted.  In the BAN2401 it changed statistical methods because it was not getting the results that it wanted.

The number of dropouts in the ApoE4 group also raises concerns not only about the safety of Biogen's anti-amyloid drugs, but also the significance of the results. There are relatively high rates of dropouts in the ApoE4 group due to adverse effects such as endema (brain swelling).  In the earlier trial for Aducanumab, about 55 percent of those with the ApoE4 gene developed endema in the highest dose group.  In the BAN2401 trial, 15 percent of those with the ApoE4 group developed endema.  When people with the ApoE4 gene dropout of a trial or drop down to a lower group, it is significant because people with the ApoE4 gene progress more rapidly during the early stages of Alzheimer's disease.  Exactly how much of the slowing down of the disease was due to the drug and how much of it was due to fewer ApoE4 participants in the highest dose groups is hard to calculate.  But when this is taken into account, the effects to Biogen's drugs are less impressive than they first appear.