Anavex Life Sciences Corp (AVXL)

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Incredibly exhaustive post from Dr. Simon Stott on his “The Science of Parkinson’s” blog covering the full 2022 landscape of clinical research focused on disease modification for Parkinson’s. Great to see his continued enthusiasm for blarcamesine in this write up: https://scienceofparkinsons.com/2022/01/20/road2022/

One of the standout results for Parkinson’s research in 2021 (based on my humble opinion) was the results of a clinical trial of a drug called Blarcamesine (previously known as ANAVEX2-73). The drug is a Sigma-1 agonist (Click here to read a review on Sigma-1 biology) and it is being developed by the biotech company Anavex Life Sciences.

This agent was being tested in a Phase 2, double-blind, placebo-controlled study, evaluating the safety, tolerability, and efficacy of blarcamesine in 132 people with Parkinson’s with dementia. The participants were treated for 14 weeks and the assessments were primarily focused on cognitive measures (Click here to read more about the details of this trial).

In June 2021, the results of the study were announced and the press release stated that “From baseline to end of trial at 14 weeks, MDS-UPDRS Total score improved by -10.98 points in the ANAVEX®2-73 high dose group and worsened by 3.53 points in the placebo group, an adjusted mean difference of -14.51 points (p = 0.034).”

This is rather jaw dropping stuff.

A 14-week study is very short, and an improvement of 11 points is simply remarkable. It corresponds to a relative improvement of almost 20% over 14 weeks (18.9% to be exact).

And it is important to remember that is that this result was achieved while the participants were on their standard medication. That is to say, the participants were on their standard PD medication (e.g. L-dopa, etc) during the clinical assessments – so the improvement in total UPDRS score was on top of the response to standard medication (Click here to read a SoPD post on this topic).

Typically, individuals with PD decline in MDS-UPDRS scores by 3.99 to 7.45 points per year (Click here to read more about this), so a 10.98 point improvement is worth noting (remember this was a double-blinded study).

A 48 week open label extension study for the participants of this study is now being conducted (Click here to read more about that study). This extension is scheduled to finish in mid 2022, so hopefully we will learn more about this research later in the year, and also be given news on the future clinical development of blarcamesine.