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Ban2401 phase 3 immunotherapy trial
LDDaughter
Posted: Wednesday, December 18, 2019 1:46 PM
Joined: 12/22/2011
Posts: 1065


Is anyone here familiar with this potential new medication in Phase 3 trials now?  The ClarityAd study or Ban2401?  For the scientists here, what are your thoughts about this given this targets amyloid and previous meds targeting amyloid have failed?   Why is it looking positive so far?  IV treatment, targeting a different mechanism?

https://clinicaltrials.gov/ct2/show/NCT03887455

https://alzheimersnewstoday.com/ban2401/

 


Lane Simonian
Posted: Wednesday, December 18, 2019 2:42 PM
Joined: 12/12/2011
Posts: 4830


These are great questions, LDDaughter.  The effectiveness of BAN2401 depends largely on APOE4 status (I think the same will also hold true for aducanumab):

Did APOE4 affect response to treatment? The subgroup analysis said yes, Swanson reported. Carriers on the highest dose had less cognitive decline at 18 months than the noncarriers or the group overall. On the ADCOMS , for example, where the highest dose group declined 30 percent less than placebo, APOE4 carriers declined 63 percent less and noncarriers only 7 percent less.

https://www.alzforum.org/news/conference-coverage/second-look-ban2401-data-still-positive-despite-snafu

Those with one or two copies of the APOE4 gene have more oxidative stress which leads to more amyloid which leads to more oxidative stress than non-carriers, so removing the same amount of amyloid from both groups is going to slow down the progression of the disease more in APOE4 carriers than non-carriers.

Biogen asserts for both BAN2401 and aducanumab that carriers are not progressing any more rapidly than non-carriers during the early stages of the disease but this contradicts several other studies.  My suspicion is that these drugs may slow down the rate of early progression in carriers to a rate similar to non-carriers.


LDDaughter
Posted: Wednesday, December 18, 2019 4:06 PM
Joined: 12/22/2011
Posts: 1065


Thank you for your quick reply Lane and sharing that link as well. I appreciate your insights on this.  A friend of mine is trying to get her husband to sign up for this trial.

Also, as many of these trials are double blind with placebos do you know of provisions where at some point they let the recipients receiving the placebo start using the medication? I read something that suggested that can happen sometimes in an article on the Alz Assoc website. 


Lane Simonian
Posted: Wednesday, December 18, 2019 10:45 PM
Joined: 12/12/2011
Posts: 4830


This has happened in the past.  Aricept comes to mind.  Not sure how likely this is to happen with Biogen's and Eisai's drugs (BAN2401 and aducanumab).
HowDoYouDeal
Posted: Saturday, December 21, 2019 3:16 PM
Joined: 2/17/2019
Posts: 347


Biogen is offering to bring back all  previous participants for everyone to take the drug, no more placebo =no more blinding, everyone gets the active drug

  When they test a drug, and its given to everyone its called an open-label STUDY

or when it does well and everyone gets to take the drug, like the aduca.... study its called an open label  EXTENTION

It's a good move for Biogen since halting the trial initially threw everyone for quite the loop.