Cassava Sciences Announces Positive Biomarker Data with Simufilam in Alzheimer’s Disease
- Simufilam Significantly Improved Biomarkers in Alzheimer’s Patients Treated for 6 Months
- Robust Improvements Seen in All Measured Biomarkers of Disease, Neurodegeneration and Neuroinflammation (p< 0.00001)
- Biomarker Improvements Track with Cognitive Improvements
- Oral Presentation at AAIC Today
In a clinical study funded by the
Cerebrospinal fluid (CSF) biomarkers of disease pathology, t-tau and p-tau181, decreased 38% and 18%, respectively (both p<0.00001). CSF biomarkers of neurodegeneration, neurogranin and Nfl, decreased 72% and 55%, respectively (both p<0.00001). CSF biomarkers of neuroinflammation, sTREM2 and YKL-40, decreased 65% and 44% (both p<0.00001). CSF biomarker data were collected from 25 patients with mild-to-moderate Alzheimer’s disease who completed 6 months of simufilam treatment in an on-going open-label study.
“Six months of simufilam treatment robustly improved brain biomarkers,” said
About Cerebrospinal Fluid (CSF) Biomarkers
A key objective of this analysis was to measure changes in levels of biomarkers in patients before and after 6 months of treatment with open label simufilam. Biomarker data were analyzed from CSF collected from 25 patients with mild-to-moderate Alzheimer’s disease who are enrolled in an on-going open-label study and who agreed to undergo a lumbar puncture at baseline and again after 6 months of treatment. All bioanalyses were conducted blind by an outside lab. Simufilam robustly improved all measured CSF biomarkers (all p-values are baseline vs. 6-month levels by paired t-test):
Core markers of Alzheimer’s pathology are total tau (T-tau), phosphorylated tau (P-tau181), and amyloid beta42 (Aβ42). In Alzheimer’s, tau levels are elevated and Aβ42 is low.
- T-tau decreased 38% (p<0.00001)
- P-tau181 decreased 18% (p<0.00001)
- CSF Aβ42 increased 84% (p<0.00001)
Elevated CSF levels of two proteins, neurogranin (Ng) and neurofilament
- Ng decreased 72% (p<0.00001)
- NfL decreased 55% (p<0.00001)
Elevated levels of marker YKL-40 indicate neuroinflammation.
- YKL-40 decreased 44% (p<0.00001)
sTREM2 is a biomarker of microglia-induced neuroinflammation that has commanded substantial recent attention from researchers for its role in Alzheimer’s and frontotemporal dementia.
- sTREM2 decreased 65% (p<0.00001)
HMGB1 protein, is a damage-related protein sometimes called a ‘danger molecule’ because it triggers additional neuroinflammation and loss of neurons.
- HMGB1 decreased 53% (p<0.00001)
This press release is contemporaneous with another press release titled, “Cassava Sciences Announces Positive Cognition Data with Simufilam in Alzheimer’s Disease”, which reports simufilam improved cognition scores by 3.0 points on ADAS-Cog at 9 months (p<0.001).
About Today’s Oral Presentation at AAIC
Today’s AAIC presentation can be accessed on the ‘Investors’ page of the Company’s website: https://www.CassavaSciences.com
About the Open-label Study
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) 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. The underlying science for simufilam is published in peer-reviewed journals, including
Simufilam and SavaDx were both developed in-house.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. As of 2020, there were approximately 50 million people worldwide living with dementia, a figure expected to increase to 150 million by 2050.1 The annual global cost of dementia is now above $1 trillion, according to Alzheimer’s
Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years,
For More Information Contact:
Cassava Sciences’ open-label study of simufilam in Alzheimer’s disease is funded by clinical research grant #AG065152 from the
The content of this press release is solely the responsibility of
Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the treatment or diagnosis of Alzheimer’s disease; the status of current and future clinical studies with simufilam, including the interpretation of interim analyses of open-label study results; plans to conduct additional interim analyses of an open-label study and the timing thereof; inherent limitations of the ADAS-Cog testing batteries; expectations regarding convergence of biomarker and cognition data, and treatment benefits of simufilam; our intention to initiate a Phase 3 clinical program with simufilam and the timing, enrollment, duration and other details thereof; verbal commentaries made by our employees; and potential benefits, if any, of our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning.
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Source: Cassava Sciences, Inc.