Another promising drug trial

Now that Aduhelm is on its way, we should remember that there are other therapeutics under evaluation.  One of those is a drug candidate known as ANVS401 (or Posiphen).  Rather than an infusion, this drug would be a conventional pill, and, after a covid-induced hiccup, it is late in its phase 2a trial.  Preliminary results have been very encouraging.

ANVS401 is being developed by Annovis Bio, a small pharmaceutical company in Berwyn, PA that specializes in a specific approach to neurodegenerative diseases.  They have a portfolio of three drug candidates that focus particularly on Alzheimer's and Parkinson's diseases.  While Aduhelm and several other Alzheimer's interventions remove accumulated amyloid and other plaques, ANVS401 attempts to prevent their generation in the first place.  

Annovis is conducting the current trial along with the Alzheimer’s Disease Cooperative Study (ADCS).  It's called The Discover Study.  It is a one-month trial studying several cohorts of subjects.  In the first cohort to finish the trial, results with 14 early stage Alzheimer's patients and 14 early stage Parkinson's patients were very promising.  Before completion of the phase 2a trial, the researchers plan to involve 68 subjects.  They hope to have results for us in July or August, so stay tuned.

The trial is measuring levels of neurotoxic proteins, neurotransmitters, neurotrophic factors, inflammation, and nerve cell death, as well as cognitive improvement.  The study is being conducted in six sites in the U.S., including the University of California San Diego, Johns Hopkins, Indiana University, Washington University, Cleveland Clinic, and Columbia University.  All subjects are not receiving the drug simultaneously.

This is a phase 2a study.  Earlier, Annovis conducted three phase 1 studies with smaller populations of test subjects.  Unlike aducanumab (now Aduhelm), there was no brain swelling and there were no micro-hemorrages.  The drug was "well tolerated." 

Annovis claims that their results with ANVS401 have been much better than the results for aducanumab at the end of aducanumab's phase 3 trial (a low bar).  This is only after one month of treatment with ANVS401.

If this trial goes as anticipated, the phase 3 trial will follow.  A phase 3 trial uses many more test subjects, and the results from these trials don't always fulfill the promises of successful phase 1 and 2 trials.