Friday, July 13, 2018

Could it be -- finally?

Will there finally be a drug to at least slow Alzheimer's disease?  This week's ALZ Forums newsletter reported on a drug study that, at the 18-month mark, was showing evidence that it could slow cognitive decline and remove amyloid plaques.  The drug is BAN2401.  It is a monoclonal antibody which selectively binds to certain amyloid cell clusters.  It appears to me that researchers had thought to abandon the trial at the 12-month mark, but persistence to 18 months is paying off.
 
This was a phase 2 trial that tested five dose regimens in people who had mild cognitive impairment due to AD or had mild AD and who had evidence of brain amyloid pathology.  Patients received infusions of a range of doses twice a month.

The trial involved 856 participants which is large for a phase 2 trial.  In fact, it's more like the size of a phase 3 trial.  Recall that, in the past, several drugs showed promise in small population phase 1 trials, but then flamed out with a larger population in phase 2.  While there may be as few as 20 subjects in a phase 1 trial, 865 participants provides much more confidence that results are meaningful!

The drug appears to be safe.  You may recall from Beating the Dementia Monster that a side effect of another monoclonal antibody, aducanumab, was causing micro hemorrhages in the brains of some subjects.  I was happy to be screened out of that one, although there is hope that it may still have a future.

BAN2401 was developed by Stockholm-based BioArctic and was then licensed to Eisai.  Biogen subsequently acquired a stake through a partnership with Eisai.  Eisai/Biogen hope to began a large phase 3 study this fiscal year.

Let us hope that continued study of BAN2401 leads to a truly effective treatment for AD!

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