Monday, February 7, 2022

All stop on atuzaginstat?

Back in January 2021 we wrote a couple of times about the proposed drug therapy atuzaginstat ... or COR388.  We also discussed it in the appendix of the second edition of Beating the Dementia Monster.  We thought it was a promising approach to treating Alzheimer's disease by going after the bacteria p. gingivalis.  We explained that there is correlation between gum disease caused by p. gingivalis and Alzheimer's disease.  We were hopeful that treating the bacteria would treat AD.  But the FDA just ordered full stop on the phase 2/3 trial.  The sponsoring company, Cortexyme, reported halting the research in this press release.  And then their stock price fell 34%.

Why the stop?  The FDA ordered it after a review of the trial data identified hepatic adverse events.  So it's about safety.  It's not clear to me if the data also showed or failed to show any improved memory or cognition.

But all is not lost.  Cortexyme has another drug, COR588, that is already in clinical trials in Australia.  It is a more advanced drug that pursues the same hypothesis as COR388 -- attacking p. gingivalis will improve memory and cognition.  It seems to be safer and more effective.

You should already know that I am somewhat skeptical of the amyloid hypothesis and its implications -- that removing beta amyloid from the brain is the right way to treat Alzheimer's disease.  This is the guiding principle behind most of the pharmaceutical therapies under development.  I'm hopeful that going after p. gingivalis instead will be more rewarding.

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