Anavex Life Sciences Corp (AVXL)

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Alzheimer’s MAB Drug Trails — All Practical Failures

As we all know, conventional medical wisdom arrogantly knows that the cause of Alzheimer's disease results from the accumulation of toxic proteins in the brain, beta-amyloids and tau plaques. Great effort has been extended to create monoclonal antibody (MAB) drugs that induce the immune system to attack and remove the waste proteins. With that, Alzheimer's would be cured.

And, of course, the MABs approved to treat Alzheimer's have all produced putatively favorable clinical results, allowing regulatory approval for their sales and therapeutic use.

But, in fact, did those clinical test results actually portend therapeutic safety and efficacy in subsequent patients not in a clinical trial? Here's what a meta-analysis of 19 studies on the matter determined:

The research team identified 19 such publications [of randomized trial studies that compared the use of amyloid-reducing monoclonal antibodies (MABs) in patients with Alzheimer dementia] that evaluated the effects of 8 different MABs on a total of 23,202 participants. Neither the results of any single study nor the results of all combined studies showed quantitative evidence that MABs improved cognitive or day-to-day functional abilities beyond the measure of minimal clinically important differences (MCIDs). Conversely, the studies indicated that MABs consistently cause statistically significant harms and could increase patients’ risk of serious harms such as cerebral edema, hemorrhage, serious adverse events, and death. Additionally, these drugs are prohibitively expensive ($26,500 to $28,200 per year) and require regular MRI monitoring.
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Although lab-based evidence shows that MABs may be a promising treatment for Alzheimer dementia, focusing on actual patient outcomes can provide a greater understanding of the potential benefits and harms of using MABs. This meta-analysis of recent clinical trials involving over 20,000 participants with Alzheimer dementia or similar cognitive impairments suggests that MABs have not been shown to lead to clinically significant improvements in cognitive or functional abilities and could potentially cause serious harm to patients taking these drugs.

But the currently-approved Alzheimer's MAB drugs all had "successful" clinical trials. Clinical endpoints were all achieved.

What, then, should count? The achievement of rigidly narrow clinical endpoints? Or overall patient health? How will blarcamesine and Anavex 3-71 be evaluated? Like the clinical trials involving the MABs? Neither Anavex drug is a monoclonal antibody. They don't provoke the problems MABs do. Mal-directed immune responses are not involved in Anavex sigma-1 receptor activation.

https://www.eurekalert.org/news-releases/1031580

https://www.annfammed.org/sites/default/files/additional_assets/PDF%20Documents/PDF/TEMPORARY_LINK_EXPIRES_JANUARY_22_2024/ebell.pdf