Approve Phase 4 trials of the drug Simufilam 21 pursuant U.S. Code § 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions.
STATEMENTS OF GROUNDS:
Top-line Results of 12-month Interim Analysis from Open-label Study Evaluating Simufilam in Alzheimer’s Disease Cassava Sciences, Inc. September 22, 2021, 8:30 am Cognition Scores Improved 3.2 Points on ADAS-Cog, Baseline to Month 12 (p<0.001)
Two Independent Biostatisticians Analyzed Changes in ADAS-Cog Scores, Baseline to Month 12
No Behavior Disorders on NPI in Over 50% Of Study Subjects at Month 12
Initiation of Pivotal Phase 3 Clinical Program Remains On-track for Q4 2021, with Special Protocol Assessments from FDA
Safety Analysis Drug is well-tolerated. There are no drug-related serious adverse events through the 12-month interim analysis.
Cassava Sciences expects to initiate its Phase 3 program with Simufilam in September 2021. Cassava Sciences Announced Top-line Results of 12-month Interim Analysis from Open-label Study Evaluating Simufilam in Alzheimer’s Disease. Cassava Sciences, in its most recent interim data release (attached), has demonstrated no serious safety events. Further Simufilam has improved cognition and NPI scores compared to Aduhelm, Donepezil, Rivastigmine, Galantamine, Memantine, and Suvorexant. While this data is Open Label, A cohort of 20,000 Alzheimer's patients was used for comparison. No medication has shown this degree and duration of cognitive and behavioral improvement.
Requesting the FDA for approval of Simufilarm considering the below.
Alzheimer's disease is the most common cause of dementia. It is s currently ranked as the sixth leading cause of death in the United States, but recent estimates indicate the disorder may rank third, just behind heart disease and cancer, as a cause of death for older adults. The estimated total healthcare costs for treating Alzheimer's disease in 2020 are estimated at $305 billion, with the cost expected to increase to more than $1 trillion. Most of the direct care costs for Alzheimer's disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated and are associated with significant negative societal and personal burdens. (https://pubmed.ncbi.nlm.nih.gov/32840331/https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm
Unfortunately, and astonishingly Alzheimer's disease does not have an effective treatment.The National Alzheimer’s Project Act (NAPA) directs the secretary of Health and Human Services (HHS) to “be responsible for the creation and maintenance of an integrated national plan to overcome Alzheimer's.” The law, co-sponsored in 2010 by Sen. Susan Collins (R-ME) and then-Rep. Edward Markey (D-MA), was passed unanimously by both Houses of Congress. It was signed into law on January 4, 2011, by President Barack Obama.
At the urging of UsAgainstAlzheimer’s (UsA2) and other advocates, the plan included a clear goal to “prevent and effectively treat Alzheimer’s disease by 2025.” The goal has driven a seven-fold increase in federal research investments – from $448 million annually in 2011 to $3.1 billion in fiscal year 2021 – that has produced significant, tangible results for the Alzheimer’s movement, most of which have arrived in just the last few years.
Just recently President Biden did say:
“You know, if we don’t do something about Alzheimer’s in America, every single, solitary hospital bed that exists in America ... every single one will be occupied in the next 15 years with an Alzheimer’s patient," he said during remarks about the economy on May 27.
Alzheimer’s Disease International reports that the ongoing Covid-19 pandemic could cause a significant rise in the number of dementia patients in the long term.
Alzheimer's disease is a terminal process with progressive decline and eventual death, and it has no effective therapy. Simufilam has demonstrated safety and promising data of improved outcomes (measured by eleven different biomarkers, ADAS cog, and NPI). It is unconscionable to with Simufilam, given Simufilam's excellent safety profile.
We request immediate initiation of Phase 4 trials for further efficacy, safety assessment, and, most critically, to address one of the greatest needs in modern medicine.