Benzinga | Jul 29, 2021 09:54AM EDT

Cassava Sciences Press Release Highlights Cognition, Biomarker Data With Simufilam In Alzheimer's Disesase

* Simufilam Significantly Improves Cognition in Patients with Alzheimer's in Interim Analysis of Open-label Study at 9 Months

* Cognition Improved 3.0 Points on ADAS-Cog at 9 Months (p<0.001)

* Cognitive Improvements Track with Biomarker Improvements

* No Behavior Disorders in Over 50% of Patients

* No Safety Issues

* Improvements in Cognition, Biomarkers and Behavior Suggest Highly Encouraging Treatment Effects

* Oral Presentation at AAIC Today

AUSTIN, Texas, July 29, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ:SAVA) announced positive clinical data today from an interim analysis of an open-label study with 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 cognition in Alzheimer's patients, with no safety issues. Simufilam improved cognition scores 3.0 points on ADAS-Cog11, an 18% mean improvement, baseline to month 9 (p<0.001). This interim analysis summarizes clinical data from the first 50 patients with mild-to-moderate Alzheimer's disease who completed 9 months of open-label simufilam treatment.

Cassava Sciences believes today's data is the first report of significant cognitive improvements at 9 months that also track with robust improvements in biomarkers in patients with Alzheimer's.

"We are very pleased with the overall consistency of data," said Remi Barbier, President & CEO. "Simufilam improved cognition, biomarkers and behavior, a triple-win for study participants. These clinical data combined with a clean safety profile and easy oral administration suggest highly encouraging and durable treatment effects for people living with Alzheimer's disease."

Alzheimer's is a progressive disease. Cognition will always decline over time. In patients with mild-to-moderate Alzheimer's disease, cognition scores decline over 4 points on ADAS-Cog over 9 months with over 90% certainty, as reported by the science literature1.

Simufilam improved ADAS-Cog scores in 66% of patients at 9 months. An additional 22% of patients declined less than reported in the science literature at 9 months. Cognition outcomes suggest simufilam's treatment effects were broad-based.

Alzheimer's is often accompanied by behaviors disorders, such as anxiety, agitation or delusions. These may become more frequent as disease progresses. Simufilam reduced dementia-related behavior at 9 months on the Neuropsychiatric Inventory (NPI), a clinical tool widely used to measure changes in dementia-related behavior.

* At baseline, 34% of study subjects had no neuropsychiatric symptoms.

* At month 6, 38% of study subjects had no neuropsychiatric symptoms.

* At month 9, over 50% of study subjects had no neuropsychiatric symptoms.

The safety profile of simufilam in the interim analysis is consistent with prior human studies. There were no drug-related serious adverse events. Adverse events were mild and transient.

"Today's data with simufilam suggests disease modification," added Nadav Friedmann, PhD, MD, Chief Medical Officer. "It appears the drug's unique mechanism of action has potential to provide transformative treatment benefits following 9 months of dosing."

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

This press release is contemporaneous with another press release titled, "Cassava Sciences Announce Positive Biomarker Data with Simufilam in Alzheimer's Disease", which reports simufilam significantly improved all measured biomarkers of disease, neurodegeneration and neuroinflammation (p<0.00001) following 6 months of open-label treatment.

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* 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

AUSTIN, Texas, July 29, 2021 (GLOBE NEWSWIRE) -- 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) 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 (A?42). In Alzheimer's, tau levels are elevated and A?42 is low.

* T-tau decreased 38% (p<0.00001)

* P-tau181 decreased 18% (p<0.00001)

* CSF A?42 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).