Aug 14, · Alzheimer's research has been hampered by apparently mistaken ideas about what causes the disease. Cassava has a new theory about what's responsible -- and Martin-Maestro P, Gargini R, Garcia E et al. Mitophagy Failure in APP and Tau Overexpression Model of Alzheimer's Disease J. Alzheimers Dis. Jun 24 [PMID: ] Lin Q, Li S, Jiang N et al. PINK1-parkin pathway of mitophagy protects against contrast-induced acute kidney injury via decreasing mitochondrial ROS and NLRP3 inflammasome Feb 02, · Ischemic heart disease (IHD), stroke, and dementia are leading causes of death and disability worldwide, 1, 2 notably affecting aging populations. The public health burden related to chest pain is substantial and the epidemiology of IHD because of large‐vessel coronary atherosclerosis is well documented. 2 By contrast, the epidemiology of small‐vessel disease (SVD) in the heart is less
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Cassava Sciences NASDAQ:SAVA is like any other unprofitable biotech -- it has a drug in clinical trials, and its investors are hoping the drug works so they can make a lot of money.
What makes Cassava really interesting thesis on alzheimers disease that it's zigging where Big Pharma is zagging regarding Alzheimer's research. For years, thesis on alzheimers disease, Alzheimer's research has been dominated by one theory, which I'm convinced is the wrong direction. Cassava has a completely different theory about the cause of Alzheimer's -- and the company has positive phase 2 data on a drug it formulated to address it.
That's gotten me excited about Cassava. But first, let's dig into why Alzheimer's research has been stuck for so long. All patients with Alzheimer's appear to display amyloid plaques -- abnormally configured proteins -- in scans of their brains.
But the reverse is not true: People can have amyloid plaques on the brain and not have Alzheimer's. This strongly suggests to me a non-scientist that amyloid plaques are not the cause of Alzheimer's. Alzheimer's research has been a graveyard for Big Pharma for decades. By one count, there have been failed drug development attempts since Almost all of this research has been based on a shaky premise -- that amyloid plaques thesis on alzheimers disease the cause of Alzheimer's.
And treatments developed on the basis of a weak theory are unlikely to succeed. This history of Alzheimer's treatment failure over two decades took a startling new turn this year. The U. Food and Drug Administration recently approved a new Alzheimer's drug, Aduhelm, from Biogen NASDAQ:BIIB. The drug showed no efficacy in actually treating Alzheimer's, which is not surprising given that it focuses on amyloid plaques.
But what shocked the world -- and the doctors on thesis on alzheimers disease advisory panel -- was that the FDA approved the drug anyway. Aduhelm failed to beat placebo. The drug successfully removed amyloid plaques -- but doing so did not help Alzheimer's patients get better. This is why the FDA's advisory panel, made up of medical doctors, voted almost unanimously to reject the drug application.
One person voted "uncertain. When some politicians in the FDA decided to approve Aduhelm anyway, three of the doctors on the advisory panel quit in disgust. And the ultimate price might be even higher.
Why would the FDA approve a drug that's no better than placebo and might cause brain bleeds? My initial reaction was that something sketchy is going on. It definitely looks bad enough that the acting commissioner of the FDA is calling for an investigation into her own agency. That said, maybe it's just a mistake. People make mistakes. And this might be a strong example of smart people falling in love with a narrative, and ignoring reality, thesis on alzheimers disease.
The narrative is that we need to get rid of those amyloid plaques. What if we quit going down that particular rabbit hole, and look at other things that might cause Alzheimer's? Maybe we'll find a drug that actually works. Alzheimer's is a huge market opportunity, which is why Big Pharma has chased it for so long. My investment thesis is that biotech companies that have abandoned the amyloid plaque theory have a much better chance of success.
Two names that popped up on my radar, thanks to my colleague Jason Hawthorneare Cassava Sciences and Annovis Bio NYSEMKT:ANVS. Cassava researchers noticed that Alzheimer's patients have a mutated protein called filamin A.
So they thesis on alzheimers disease a drug that fixes this mutation, and restores its proper form and function. The drug's phase 2 data is really strong, so my family bought some shares of the company.
I considered investing in Annovis, too. Annovis has a drug candidate that targets multiple proteins, including amyloid proteins. The thesis on alzheimers disease claims that its drug works on Parkinson's as well as Alzheimer's -- but it's only been tested in four people. While the phase 2 trial is larger 69 people54 people in the study have Parkinson's, not Alzheimer's.
An early data release, which sent the stock down in a big way, only involved 14 people. That's not enough cash for a phase 3 trial. The hope, of course, is that the stock goes up enough that the company can sell shares and fund pivotal trials, thesis on alzheimers disease. Without money, the drug is stalled. By the end ofthesis on alzheimers disease, we expect to have conducted two pivotal studies for ANVS, one in [Alzheimer's disease in patients with Down syndrome] and one in [Parkinson's disease], and to have filed one or two new drug applications "NDA" with the U.
Food and Drug Administration "FDA". Annovis' optimistic scenario is that it will have the thesis on alzheimers disease to thesis on alzheimers disease its phase 3 trials in But Alzheimer's in people with Down's is a tiny market opportunity. Right now, the company has no plan for a phase 3 trial in Alzheimer's patients aside from the Down's cohort. And it has no money for such a trial, in any case. Cassava, in sharp contrast, is starting its phase 3 trial in Alzheimer's patients later this year.
While the company is small, its science has been partially funded by the National Institutes of Health. And so far, the stock has been a wild ride for early investors. The company's drug could still fail, thesis on alzheimers disease, of course. Even if Cassava is pursuing the right theory -- always a question mark -- its execution might be off. But the way investors avoid too much pain is by making a small investment. If the pivotal trial later this year is successful, the upside is huge.
And if the drug disappoints, your downside is limited. Discounted offers are only available to new members. Stock Advisor will renew at the then current list price. Average returns of all recommendations since inception, thesis on alzheimers disease.
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Fool Podcasts. New Ventures. Search Search:. Taylor Carmichael TMFSaintCroix. Aug 14, at AM, thesis on alzheimers disease. Author Bio Taylor Carmichael is a former attorney and filmmaker. He's the author of a line of murder mysteries, including Whodidit in the Supreme Court?
and Whodidit With a Senator? The majority of what he knows about stocks he learned right here at the Motley Fool. Image source: Getty Images. Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer. Join Stock Advisor Discounted offers are only available to new members.
Stock Advisor launched in February of SAVA Cassava Sciences, Inc. NASDAQ: SAVA, thesis on alzheimers disease. BIIB Biogen Inc. NASDAQ: BIIB. ANVS Annovis Bio, Inc. NYSEMKT: ANVS. Related Articles.
Inside Alzheimer’s disease
, time: 4:20Why Might Cassava Succeed With Its Alzheimer's Drug, When So Many Have Failed? | The Motley Fool
Oct 21, · The Taking of Deborah Logan: Directed by Adam Robitel. With Jill Larson, Anne Ramsay, Michelle Ang, Brett Gentile. An elderly woman battling Alzheimer's disease agrees to let a film crew document her condition, but what they discover is something far more sinister going on Feb 02, · Ischemic heart disease (IHD), stroke, and dementia are leading causes of death and disability worldwide, 1, 2 notably affecting aging populations. The public health burden related to chest pain is substantial and the epidemiology of IHD because of large‐vessel coronary atherosclerosis is well documented. 2 By contrast, the epidemiology of small‐vessel disease (SVD) in the heart is less Martin-Maestro P, Gargini R, Garcia E et al. Mitophagy Failure in APP and Tau Overexpression Model of Alzheimer's Disease J. Alzheimers Dis. Jun 24 [PMID: ] Lin Q, Li S, Jiang N et al. PINK1-parkin pathway of mitophagy protects against contrast-induced acute kidney injury via decreasing mitochondrial ROS and NLRP3 inflammasome
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