Cassava Sciences (SAVA) Announces Biomarker Data with Simufilam in Alzheimer’s Disease

Cassava Sciences, Inc. (Nasdaq: SAVA) today announced positive biomarker data from an open-label study of simufilam, the Company’s investigational drug for the treatment of Alzheimer’s disease.

In a clinical study funded by the National Institutes of Health (NIH), simufilam significantly improved all measured biomarkers in patients with Alzheimer’s disease following 6 months of open-label treatment. Biomarkers are objective biological data. There are no placebo effects.

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 Remi Barbier, President & CEO. “In this same study simufilam also improved cognition. These data suggest simufilam has potential to provide durable treatment effects for people living with Alzheimer’s.”

About Cerebrospinal Fluid (CSF) BiomarkersA 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 Light Chain (NfL) indicate neurodegeneration.

• 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)

In February 2021, Cassava Sciences reported that simufilam improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline, following six months of open-label treatment.

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 AAICLindsay Burns, Senior VP, Neuroscience at Cassava Sciences, is scheduled to give a live podium presentation today at the Alzheimer’s Association International Conference (AAIC) in Denver, CO and virtually. Dr. Burns’ presentation is titled, “Encouraging Interim Results at 9 Months from an Open-label Study of Simufilam in Alzheimer’s Disease” (AAIC abstract #54395).

Today’s AAIC presentation can be accessed on the ‘Investors’ page of the Company’s website: https://www.CassavaSciences.com

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