BREAKING: Anavex’s Blarcamesine reduces plaque in Alzheimer’s brains without dangerous side effects
Anavex Life Sciences held their first quarter 2024 conference call today, and the company shared new information regarding their Alzheimer’s drug, Blarcamesine.
The European Union is currently working with Anavex to examine Blarcamesine’s clinical trial results and other factors for possible approval for use in combating Alzheimer’s Disease.
The U.S. FDA currently is not evaluating Blarcamesine for approval in the United States.
Today, Anavex Life Sciences CEO Christopher Missling discussed data from the Phase 2b/3 drug trial of Blarcamesine showing that the drug lowered the level of beta amyloid plaques in the brains of Alzheimer’s patients. This result was actually somewhat surprising, as, according to Dr. Missling Blarcamesine is designed to alter brain chemistry upstream from the production of beta-amyloid.
Unlike Biogen’s Lecanemab, Blarcamesine is not designed to clear beta-amyloid plaques from the brain.
The implication seems to be that Blarcamesine, working upstream, prevents the production of these plaques rather than clearing them out.
Another possible implication is that Blarcamesine helps the brain with autophagy — regulating itself and recycling cell parts. Dr. Missling has noted in the past that the drug is designed to help with autophagy.
Through autophagy, then, the brain may be clearing the plaques on its own, as spurred on by Blarcamesine.
In the conference call, Dr. Missling also noted that the drug trial demonstrated that Blarcamesine prevents brain shrinkage among Alzheimer’s patients. In fact, in my reading of the results, this was perhaps the most statistically significant finding of the entire drug trial.
When I say “brain shrinkage” I mean the loss of brain mass: losing millions of brain cells. I have seen this loss in my mother’s brain scans; my mother suffers from Alzheimer’s Disease.
Could the preservation of brain mass be an effect of the autophagy that Blarcamesine may or may not be maintaining? I would like to know, as I am also at high risk of developing Alzheimer’s — because my mother has it, and because I believe she had signs of it long before retiring from work.
Well, we will learn more about the effects of Blarcamesine soon, as Dr. Missling mentioned that their ongoing 96-week extension study will post some results in the summer. This study program provides people who were in the Phase 2b/3 trial the opportunity to continue taking Blarcamesine for 96 weeks; it does not matter if they were part of the treatment arm or the placebo arm.
Will Blarcamesine be approved for use? According to Dr. Missling, the probabilities have improved, as the U.S. FDA announced that proof of efficacy could be shown solely by demonstrating a slowing of cogntive decline in the ADAS-Cog scores of trial participants. The ADAS-Cog is a test of cognitive ability and can indicate the degree to which dementia has progressed.
This is what Dr. Missling said:
We’re encouraged by the very recently issued FDA guidance for early Alzheimer’s disease which states that one cognitive measure alone like ADAS-Cog could be a sufficient primary endpoint for early Alzheimer’s disease.
We appreciate this new guidance and believe this opens another possible pathway for us to move forward in parallel to the initiated process of market authorization application to the European Medicine Agency, EMA, for blarcamesine for the treatment of Alzheimer’s disease which is already underway.
So, Dr. Missling believes that the FDA approval process may go forward, or may go forward more quickly now, because, it seems Anavex Life Sciences only has to demonstrate that it has slowed the deterioration of ADAS-Cog scores for it trial participants.
While the ADAS-Cog is focused on cognition, other tests are more focused on behavior: how well is the person eating, dressing themselves, doing daily chores, etc. These other tests may also be based on the input of caregivers, whereas the ADAS-Cog is a test that involves only the patient suffering from dementia.
While Blarcamesine proved to be effective in slowing cognitive decline as demonstrated by the ADAS-Cog, it did not perform as well on the behavioral tests.
Further, the FDA has in the past shown extreme favoritism for the big pharma company, Biogen. See my previous articles.
If Blarcamesine were to be evaluated solely on the ADAS-Cog, it would almost certainly be approved, as the drug demonstrated that it slowed cognitive decline to the same degree as the approved treatment, Biogen’s Lecanemab. Furthermore, Blarcamesine is far safer than Lecanemab, which can cause death through brain bleeding.
Lecanemab clears plaques from the brain, but its mechanism of action often results in the swelling and bleeding of the brain. The drug, approved by the FDA, has a serious warning label, and doctors must regularly take MRI scans of patients to monitor for brain swelling and bleeding, which has resulted in an unknown number of deaths so far.
As I wrote in a previous article, I pressed Biogen on how many patients died in their clinical trials as a result of brain bleeding, and their patient liaison could not or would not answer my question, even though I told them that I was considering Lecanemab for my mother (who suffers from Alzheimer’s).
We will learn more soon about Anavex’s Blarcamesine. A journal article with full data set is coming, according to Dr. Missling. I expect it this summer, as the article has been discussed for the past three quarterly conference calls. And data from the 96-week extension trial should also be released this year.
My sense is that the drug is effective. But even if it’s not clearly effective according to the FDA, I would like to have the opportunity to find out for myself. I hope the EU approves the drug so that I can travel there and buy some for my mother and save some for myself.