And what about BAN2401? Remebmer that one?

So aducanumab seems to have flamed out (at least for now), but we have prospects in several other pharmacological candidates, including (but not limited to) NLY01 and AMX0035.  But back in 2018 we wrote hopefully about another monoclonal antibody, BAN2401.  What's going on with that?

Well, a lot.  At the recent Clinical Trials in Alzheimer's Disease conference, the Japanese pharmaceutical company, Esai Ltd., presented results of their phase 2 trial showing that amyloid plaques "plummeted" in test subjects receiving the treatment.  Esai has now recruited 1,200 test subjects for a phase 3 trial for people with MCI. 

BAN2401 was originally developed by the Swedish pharmaceutical company BioArctic.  Bioarctic licensed it to Esai, who subsequently partnered with Biogen to pursue development.

In 2018 they had established that BAN2401 could remove plaques, but the question was, does that lead to cognitive improvement?  The early test results indicated that it probably could if you kept people on it long enough -- and well after it seemed the plaques were gone.

But there's more.  The Alzheimer's Clinical Trial Consortium has begun separate phase 2 and phase 3 studies to measure whether BAN2401 can treat early stage and pre-clinical Alzheimer's disease.  Early stage subjects are being chosen based on evidence in cognitive tests, where they show the earliest Alzheimer's symptoms.  Two other studies, called Ahead345, will see if the treatment can prevent the onset of memory loss.  Since March 2019 they have been looking for subjects age 55-80 who are at risk of developing memory loss from Alzheimer's disease.  

It was not clear to me how they are identifying pre-clinical test subjects, but similar research has relied on genetic tests for the genes most responsible for young onset Alzheimer's disease.  This points to our very great need for blood tests and other diagnostic tools for identifying pre-clinical cases.

The bad news is that this stuff takes time, and covid isn't helping.  The test that began recruiting in 2019 is still not full, and these tests take as long as four years to produce data. 

You can read more here.