Biogen Product Adulelm Approved for Alzheimer’s Disease
The latest news regarding Alzheimer’s disease is that of the FDA’s approval of Biogen Inc’s (BIIB) Alzheimer disease product Adulelm (aducanumab). Although the approval seemed to be great news for Biogen many analysts and researchers, in highly regarded scientific institutions and universities, called it controversial. The FDA advisory committee has voted almost unanimously against approving Adulelm (aducanumab) for the treatment of Alzheimer’s Disease.
Looking at the reasoning behind Adulelm’s (aducanumab) unexpected approval we realized that the decision was based on the fact that this monoclonal antibody is targeting the amyloid protein that causes the accumulation of plaques in the brain. The product has successfully lowered the targeted amyloid protein, hence reducing the brain plaques. The lowering of amyloid is being considered a biomarker that qualifies the product for accelerated approval.
What if a successful lowering of the amyloid protein does not succeed in slowing the cognition decline in the demented patients? Should the drug that reduces the amyloid protein still be considered a biomarker that accelerates the approval of investigational Alzheimer’s products?
Many expert researchers in Alzheimer’s disease who are against the approval, or voted against it, confirmed that many other existing products have lowered amyloid and have all still, yet, failed to improve Alzheimer patients’ cognition. They also wrote about the serious adverse effects Adulelm is causing including brain swelling and micro hemorrhaging in addition to other adverse events that make the risk outweigh the drug’s efficacy.
From the Experts
Following the FDA approval, David S. Knopman, a neurologist at Mayo Clinic told the Washington Post, “The whole saga of the approval of aducanumab made a mockery of the advisory committee’s consultative process. While I realize that the committee is advisory, the approval of aducanumab appears to have been foreordained.” Earlier, Joel S. Perimutter, a neurologist at Washington University in St. Louis announced his resignation from the FDA advisory committee. Perimutter told STAT that he resigned due to “this ruling by the FDA without further discussion with the advisory committee.”
Better Alzheimer’s Disease Drugs are in the Making
Professors and scientists in highly regarded medical universities and institutions mentioned that other investigational products in clinical trials are demonstrating improvements in patient’s cognition. These targeted products do not target amyloid protein but have other targets based on a more advanced understanding of the causes of Alzheimer’s disease.
Another firm with an Alzheimer’s disease product that has a different target is Cassava Sciences (SAVA) – a clinical-stage firm, created a product called Simufilam which demonstrated promising results in Alzheimer’s patients’ cognition.
Simufilam is a small molecule oral drug that aims at restoring the shape and normal function of altered filamin A, which is a scaffolding protein in the brain. When altered, this protein in the brain disrupts the normal function of the neurons, leading to Alzheimer’s pathology – neurodegeneration and neuroinflammation.
So, Cassava Sciences product Simufilam does not target amyloid protein but another protein in the brain.
The underlying science for Cassava’s product Simufilam is published in various journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease.
In addition to Simufilam, Cassava is developing a diagnostic test called SavaDx to detect Alzheimer’s disease with a simple blood test.
Other companies are also developing products with different targets. Some have demonstrated promising results with regard to slowing the deterioration of the patients’ cognition.
The market is in the billions of dollars.
The controversial FDA approval of Biogen’s product Adulelm (aducanumab) for Alzheimer’s disease will continue to be discussed by the experts in dementia so the patients and their physicians might clearly see the whole picture and make the correct choice regarding the prescription of the drug.
In the meantime, we remind that Cassava Sciences is initiating a Cognition Maintenance Study (CMS) to further evaluate Simufilam in patients with Alzheimer’s disease. Notably, Cassava Sciences believes the ability to impact more than one aspect of Alzheimer’s disease represents a new and crucial approach to treatment.
From Cassava Sciences
Remi Barbier, President & CEO, Cassava Sciences, informed, “The CMS is a randomized, controlled study designed to evaluate changes in cognition over six months in study participants who continue with drug treatment versus those who stop treatment. We believe clinical data from the CMS may inform the benefit-risk assessments that drive regulatory decisions.”
In addition to initiating the CMS and conducting an ongoing open-label study, Cassava Sciences’ strategic focus for 2021 is advancing the firm’s Simufilam in a Phase 3 program in Alzheimer’s disease to complete clinical readiness activities in support of the Phase 3 program and to continue leading the Company in delivering the full potential of its product portfolio.
We will follow up on the other firms that are demonstrating promising cognition results in patients with Alzheimer’s disease as well.
Prohost Biotech’s Current Plans and Future Focus
In the upcoming Prohost Letter #446, subscribers will learn that Prohost Biotech’s current focus is on finding biotechnology and biopharmaceutical firms capable of developing effective treatments for severe debilitating and life-threatening diseases that have yet to find effective treatments. Our selection of these firms has always been based on solid scientific fundamentals which enable them to discover and offer proof of concept of pathways for the condemning of severe diseases, hence, designing effective treatments that aim at the right targets.
Currently, clinical answering to patients inflicted with untreatable conditions is condemnation. However, under certain circumstances, condemned patients are offered therapies that are neither safe nor effective. It is far better not to prescribe those treatments as they would accentuate the patients’ misery rather than helping relieve it.
Among the diseases that attracted our attention are hereditary and non-hereditary genetic diseases, metabolic diseases, resistant cancer (brain cancer, triple-negative breast cancer, stomach cancer, pancreatic cancer as well as other cancers) and neurodegenerative diseases comprising debilitating and deadly diseases including Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s diseases and many other neurodegenerative diseases and syndromes.
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