If not BAN2401, what about Atuzaginstat? (Say that 3 times fast.)

Back in February 2019, we wrote about the bacterium p. gingivalis, reporting the growing evidence that it may play a role in Alzheimer's disease.  We discussed this further in the second edition of Beating the Dementia Monster.  The microbe causes gum disease, and some believe it may be the sole cause of Alzheimer's disease.  Whether it's the sole cause or not, interest in the role of p. gingivalis has been growing, and one drug is showing particular promise as a treatment.  That drug is COR388 or Atuzaginstat.  A stage 2/3 clinical trial just passed an important milestone that's worth talking about.

The drug was developed by the biopharmaceutical company Cortexyme.  The trial involves about 640 test subjects and is intended to run for a year.  In December, the trial reached the 6-month point, and an independent committee reviewed the results so far in what's called a futility study.  This was intended to determine if there is enough evidence of the drug's efficacy and safety to justify continuing the trial.  You may recall that some trials of aducanumab were terminated by a futility study, when they failed to meet some interim goals.  

So the big news is that the independent Data Monitoring Committee reviewed the 6-month data for 300 of the test subjects and found sufficient evidence of safety and efficacy to recommend continuing the trial to the end.  That's good news, because this system is intended to protect people from unnecessary exposure to experimental drugs that may be dangerous and/or ineffective.  Presumably, the committee found good evidence that the drug is both safe and effective.

Cortexyme expects to complete the trial, process the data, and present the final results by December 2021.

P. gingivalis is known to generate an enzyme called gingipain which causes inflammation.  This occurs first in gum disease, but p. gingivalis and gingipain can almost always be found in the brains of people deceased with Alzheimer's disease.  Atuzaginstat targets the generation of gingipain.

In the past month or so we have reviewed the status of an array of promising treatments for Alzheimer's disease.  Alzheimer's disease is very complex, and these treatments target different mechanisms influencing how the disease develops.  Many believe that we will eventually be treating Alzheimer's disease simultaneously with several different drugs.  Perhaps Atuzaginstat will be one of them.