Tuesday, November 17, 2020

If not aducanumab, how about NLY01?

Hope springs eternal (and it should) for a pharmacological silver bullet for Alzheimer's disease.  It may turn out that aducanumab can help some, but it's not a cure.  We wrote previously about BAN2401, and it is still in trials.  So who knows?  

Among other possibilities is a candidate called NLY01.  It's developer and sponsor, Neuraly, is, of course, quite enthusiastic about this drug.  On November 2, they announced that the FDA has cleared the way for them to begin a new phase 2 trial of the drug which, among other things, has been shown to reduce neuroinflammation.  The drug is already in a phase 2 trial for treatment of Parkinson's disease, so the new Alzheimer's trial is referred to as a phase 2B trial.  So far, it seems safe, but will it work for either Parkinson's or Alzheimer's?

In the new edition of Beating the Dementia Monster, we discussed the role of microglia in Alzheimer's disease.  Microglia are cells in the brain that can help clean up the trash from Alzheimer's disease -- beta amyloid and tau tangle residues -- but at the price of increased inflammation.  (The trash promotes the spread of the disease in the brain.)  Neuroinflammation from microglial activity is especially a problem with older brains, because the behavior of microglia changes over time.  We discussed this here about a year ago.  This article in Nature Medicine discusses how NLY01 can suppress neuroinflammation by suppressing microglial activity.

Neuraly expects to enroll about 500 test subjects at about 100 test sites across the US, Canada, and Europe.  They anticipate results in the fourth quarter of 2023.  So it'll be a while.

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