Blarcamesine: “Biomarker Cure” or Strong Efficacy AAIC San Diego 2022 $AVXL Anavex2-73

Do not trade this blog as 4 billion years of evolution is against me and possibly even God laughs at it, He has a great sense of humor!

Is Anavex Corroborating Efficacy of Balcamesine in Azheimer’s Trials Or Is It Taking From The Big Pharma Playbook The “Biomarker Cure”?

On the webpage of Alzheimer’s Association International Conference held in San Diego, USA July 31-August 2 2022 folowing information about poster by Anavex can be found.

The title of the poster is; Study of the mechanism of action of Blarcamesine (ANAVEX2-73): Whole blood transriptomics analysis identifies treatment impact on compensatory pathways by restoring key neurodegenerative pathways funtionality, including Alzheimer’s disease pathway. The poster to be available on line to be dowloaded by Saturday, July 30 at 11:00 AM PDT.

The question is what is Dr. Missling looking for in the blood of the Phase2b/3 subjects? Two posible secenarior come to mind. Either the drug has shown overwhelming efficacy and to support its claimes Dr. Missling is extending the analysis to proteins in blood to counter the lack of direct knowledge of MOA of Blarcamsine, or Dr. Missling follows the logic of Big Pharma when they claim to affect Alzheimer’s by the proxy of the only apporoved by FDA biomarkers that are amyloid plaque or Tau tangles.

The list of authors might give us a clue.

Most of them are coming from Ariana Pharma. From the previous enagagements of Ariana with ANAVEX2-73 one can draw the conclusion that this is not a simple analysis of one or two biomarkers but a complex net of connections of the changes in the subject’s blood over dosing the drug. Ariana uses AI engine to connect changes in hundreds of compounds or proteins (or related genes) to the response of the patients. It seems that currently, the only limitation is ability to identify the relevant proteins in the blood. Rest assured that at present the number indentified protein related to their genes has been ever growing, espacially after alleged gene had been read. RNA fragment give a clue what genes were actived and what were atenuated, alternatively protein level might thell the story. The hypothesis of MOA of Blarcamesine stipulates release of plethora of proteins to rescue the stressed cellular physiology, besided this Blarcamesine is thought to activate certain genes, this also should be included in the scope of the study.
Running such analysis seems unwarranted without clear efficacy of the drug. Otherwise it becomes an exercise in proxy of MOA as the molecural mechanism is still unknown but identifies the pathways to be further investigated. The use of the word “compensatory” implies that most of the changes involve some response mechanism to repair the damaged neurons or that to some extend the changes might not indicated any known pathways as of yet. The use of the word “key” suggests effects concentrated in few proteins (compounds or genes) deemed to be important to the neurodegenerative disease either known or to be identified, which again makes no sense without strong efficacy. Either way, a profound impact of dosing with Blarcamesine on known blood chemistry has been observed. In light of the title semantics, one can expect Blarcamesine to change the blood chemistry. These changes alone are meaningless without profound efficacy.

At about 500 participants the study shall be statistically significant. As the molecular MOA of Balcamesine is still being hypothesised the pharmacological consequences of Blarcamesine dosing are being documented. Connecting them to patient’s responces might be paradigm change in treatment of neurodegenerative diseases. In previous runs Ariana made astounding number of tentative connections and then pruned them to arrive with strong connections on sample size of just few tens of patients. I believe this study will be more more definitive as its scpoe might also include genetic factors. The detractors of $AVXL has claimed that Dr. Missling has never “proven” efficacy like other companies with multiple biomarkers, predominatly by lowering of biomarkers connected with neuroinflamation. This might be their moment of truth.

It shall make for interesting Saturday, July 30, 2022.

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