$SAVA Monster Writeup Part 1: The Holy Grail of Pharmaceutical Research

ALRIGHT. This is the only $SAVA DD you'll need to read to understand what's going on with Alzheimer's research. I broke it up into 3 parts so your tiny attention spans would be able to read it over time. This is the first part, the part none of you think is necessary: Necessary Background Knowledge. If you would like to learn more about Simufilam trials, you can find patient information and trial sites here. TLDR: Alzheimer’s is the most common form of dementia. 50 Million people worldwide and 5.8 Million in the United States have Alzheimer’s. There is no cure for Alzheimer’s and no way to definitively diagnose it. Untreated, people with Alzheimer’s always get worse. Current treatments (Aduhelm, Aricept) suck as they only slow the decline of patients with Alzheimer’s. Current diagnostic methods suck for Alzheimer’s because they involve a multistep process of family interviews, brain scans, or memory/cognition tests. Alzheimer's Disease Fact Sheet Alzheimer's is the most common cause of dementia. Alzheimer's is a progressive disease, where dementia symptoms gradually worsen over a number of years. [source] The risk of Alzheimer's disease and other types of dementia increases with age. Alzheimer's is the sixth-leading cause of death in the United States. [source] 6.2 Million Americans have Alzheimer's. By 2050, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 12.7 million in the US. As the size and proportion of the U.S. population aged 65 and older continue to increase, the number of Americans with Alzheimer’s or other dementias will grow. This number will escalate rapidly in coming years, as the population of Americans age 65 and older is projected to grow from 55 million in 2019 to 88 million by 2050. The baby boom generation has already begun to reach age 65 and beyond, the age range of greatest risk of Alzheimer’s dementia. [source] More than 18.5 Billion hours of informal care were provided by Alzheimer's and other dementia caregivers in 2018, a contribution to the nation valued at nearly $234 billion. The total lifetime cost of care for someone with dementia was estimated at $350,174 in 2018 dollars. The costs associated with family care make up 70 percent of lifetime dementia care costs. [source] Alzheimer's has no cure. Treatments include Aducanumab, and Aricept (cholinesterase inhibitor). Aricept is an old drug that can temporarily slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer's and their caregivers [source]. Aducanumab, recently approved by the FDA, is highly controversial as it was approved without indication that it improved cognition in patients. Alzheimer’s is best diagnosed early, since all treatments are for early-to-moderate Alzheimer’s [article]. Doctors diagnose Alzheimer's disease using in person tests administered to assess memory and thinking skills. Laboratory and imaging tests can rule out other potential causes or help the doctor better identify the disease causing dementia symptoms. Alzheimer's disease is only diagnosed with complete certainty after death, when microscopic examination of the brain reveals the Amyloid plaques and Tau tangles. Amyloid Hypothesis and Tau Tangles Beta-amyloid is a sticky compound that accumulates in the brain, disrupting communication between brain cells and eventually killing them. Some researchers believe that flaws in the processes governing production, accumulation or disposal of beta-amyloid are the primary cause of Alzheimer’s. This theory is called “the amyloid hypothesis.” [source] Amyloid plaques are hard, insoluble accumulations of beta-amyloid proteins that clump together between the nerve cells (neurons) in the brains of Alzheimer’s disease patients. [source] Aducanumab (Biogen) and Donanemab (Eli Lilly) are monoclonal antibodies that target beta-amyloid in soluble and insoluble form. These drugs seek to remove amyloid plaques from the brain. Unfortunately, while they have been shown to reduce amyloid from the brain, they have not been shown to improve cognition. Both drugs are administered via IV infusion. [source] Tau tangles, another hallmark of Alzheimer's, are insoluble twisted fibers found inside the brain's cells. These tangles consist primarily of a protein called tau. In Alzheimer's disease, the tau protein is abnormal and misfolded. Cassava Sciences, Simufilam, and SavaDX Cassava Sciences (SAVA) is a clinical stage pharmaceutical company. Its mission is to develop a treatment and diagnostic for Alzheimer’s disease. Simufilam is a proprietary, small molecule oral (pill) drug that restores the normal shape and function of altered Filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Importantly, Simufilam does not attempt to target amyloid-beta and remove it from the brain. Simufilam is protected by patents running till 2037. SavaDx is an investigational blood test to detect Alzheimer’s disease. SavaDX is protected by trade secrets. A sneak peek into tomorrow's DD I believe Simufilam has the potential to be one of the best selling drugs in pharmaceutical history. Stay tuned for the next DD! Positions: 3954 SAVA, $10c 01/21/22, $20c 01/21/22, $45c 01/21/22, $22.5c 01/20/23 If you would like to learn more about Simufilam trials, you can find patient information and trial sites here.

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$SAVA Monster Writeup Part 1: The Holy Grail of Pharmaceutical Research

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ALRIGHT. This is the only $SAVA DD you'll need to read to understand what's going on with Alzheimer's research. I broke it up into 3 parts so your tiny attention spans would be able to read it over time. This is the first part, the part none of you think is necessary: Necessary Background Knowledge.

If you would like to learn more about Simufilam trials, you can find patient information and trial sites here.

TLDR:

  1. Alzheimer’s is the most common form of dementia. 50 Million people worldwide and 5.8 Million in the United States have Alzheimer’s. There is no cure for Alzheimer’s and no way to definitively diagnose it. Untreated, people with Alzheimer’s always get worse.
  2. Current treatments (Aduhelm, Aricept) suck as they only slow the decline of patients with Alzheimer’s. Current diagnostic methods suck for Alzheimer’s because they involve a multistep process of family interviews, brain scans, or memory/cognition tests.

Alzheimer's Disease Fact Sheet

  • Alzheimer's is the most common cause of dementia.
  • Alzheimer's is a progressive disease, where dementia symptoms gradually worsen over a number of years. [source]
  • The risk of Alzheimer's disease and other types of dementia increases with age. Alzheimer's is the sixth-leading cause of death in the United States. [source]
  • 6.2 Million Americans have Alzheimer's. By 2050, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 12.7 million in the US. As the size and proportion of the U.S. population aged 65 and older continue to increase, the number of Americans with Alzheimer’s or other dementias will grow. This number will escalate rapidly in coming years, as the population of Americans age 65 and older is projected to grow from 55 million in 2019 to 88 million by 2050. The baby boom generation has already begun to reach age 65 and beyond, the age range of greatest risk of Alzheimer’s dementia. [source]
  • More than 18.5 Billion hours of informal care were provided by Alzheimer's and other dementia caregivers in 2018, a contribution to the nation valued at nearly $234 billion. The total lifetime cost of care for someone with dementia was estimated at $350,174 in 2018 dollars. The costs associated with family care make up 70 percent of lifetime dementia care costs. [source]
  • Alzheimer's has no cure. Treatments include Aducanumab, and Aricept (cholinesterase inhibitor). Aricept is an old drug that can temporarily slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer's and their caregivers [source]. Aducanumab, recently approved by the FDA, is highly controversial as it was approved without indication that it improved cognition in patients.
  • Alzheimer’s is best diagnosed early, since all treatments are for early-to-moderate Alzheimer’s [article]. Doctors diagnose Alzheimer's disease using in person tests administered to assess memory and thinking skills. Laboratory and imaging tests can rule out other potential causes or help the doctor better identify the disease causing dementia symptoms. Alzheimer's disease is only diagnosed with complete certainty after death, when microscopic examination of the brain reveals the Amyloid plaques and Tau tangles.

Amyloid Hypothesis and Tau Tangles

Beta-amyloid is a sticky compound that accumulates in the brain, disrupting communication between brain cells and eventually killing them. Some researchers believe that flaws in the processes governing production, accumulation or disposal of beta-amyloid are the primary cause of Alzheimer’s. This theory is called “the amyloid hypothesis.” [source] Amyloid plaques are hard, insoluble accumulations of beta-amyloid proteins that clump together between the nerve cells (neurons) in the brains of Alzheimer’s disease patients. [source]

Aducanumab (Biogen) and Donanemab (Eli Lilly) are monoclonal antibodies that target beta-amyloid in soluble and insoluble form. These drugs seek to remove amyloid plaques from the brain. Unfortunately, while they have been shown to reduce amyloid from the brain, they have not been shown to improve cognition. Both drugs are administered via IV infusion. [source]

Tau tangles, another hallmark of Alzheimer's, are insoluble twisted fibers found inside the brain's cells. These tangles consist primarily of a protein called tau. In Alzheimer's disease, the tau protein is abnormal and misfolded.

Cassava Sciences, Simufilam, and SavaDX

Cassava Sciences (SAVA) is a clinical stage pharmaceutical company. Its mission is to develop a treatment and diagnostic for Alzheimer’s disease.

Simufilam is a proprietary, small molecule oral (pill) drug that restores the normal shape and function of altered Filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Importantly, Simufilam does not attempt to target amyloid-beta and remove it from the brain. Simufilam is protected by patents running till 2037.

SavaDx is an investigational blood test to detect Alzheimer’s disease. SavaDX is protected by trade secrets.


&auto=webp&s=16d56fa04a54b5c3a6f4ba35a7cd6755d926f832">A sneak peek into tomorrow's DD

I believe Simufilam has the potential to be one of the best selling drugs in pharmaceutical history. Stay tuned for the next DD!

Positions: 3954 SAVA, $10c 01/21/22, $20c 01/21/22, $45c 01/21/22, $22.5c 01/20/23

If you would like to learn more about Simufilam trials, you can find patient information and trial sites here.

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