Home Actualité internationale World news – Cassava Sciences’ Simufilam Improves Alzheimer’s Disease Perception and Behavior in Interim Open Study Analysis
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World news – Cassava Sciences’ Simufilam Improves Alzheimer’s Disease Perception and Behavior in Interim Open Study Analysis

– Patient perception improved 1.6 points on ADAS-Cog11 – Patient behavior improved 1.3 points on NPI –

AUSTIN, Texas, February 2, 2021 (GLOBE NEWSWIRE ) – Cassava Sciences, Inc. (Nasdaq: SAVA) today announced the results of an interim analysis of an open study of simufilam, its lead drug candidate for the treatment of Alzheimer’s disease. Patients’ cognitive and behavioral scores improved after six months of simufilam treatment without any safety issues.

In a clinical study funded by the National Institutes of Health and conducted by Cassava Sciences, six months of simufilam treatment improved ADAS-Cog11 cognitive scores 1.6 points, which corresponds to a mean improvement of 10% over the initial value up to the 6th month. In the same patients Simufilam In addition, dementia-related behavior such as anxiety, delusions and restlessness improved in the neuropsychiatric inventory by 1.3 points, which corresponds to an average improvement of 29% from the baseline by the 6th month.

Alzheimer’s is one progressive disease. Over time, a patient’s perception will always deteriorate. « Experience based on longitudinal studies of outpatients with mild to moderately severe Alzheimer’s disease suggests that ADAS tooth values ​​decrease by 6 to 12 points per year, » says the FDA’s prescription information sheet for ARICEPT® (Donepezil ), one for the treatment of Alzheimer’s dementia type 1: « We couldn’t be more satisfied with these interim results, » said Remi Barbier, President of &, CEO. “We would have been happy to show that simufilam stabilizes cognition in patients for 6 months. Improvements in cognition and behavior show that this drug candidate has the potential to offer lasting treatment effects to people with Alzheimer’s disease. It’s an exciting development. « 

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

 » Today’s data again suggest that Simufilam could be a transformative, novel therapeutic, « added Dr. med. Nadav Friedmann, Chief Medical Officer. » It appears that the drug’s unique mechanism of action may provide a treatment benefit after 6 months of dosing. « 

Information on the Interim Analysis The ongoing one-year, open-label, multicenter study by Cassava Sciences is evaluating the long-term safety and tolerability of simufilam 100 mg twice daily in 100 patients with mild to moderate Alzheimer’s disease. This study began in March 2020 and is now approximately 80% enrolled. Today’s pre-planned interim analysis summarizes the clinical data in the middle the registration together, d. H. The first 50 patients who completed at least 6 months of drug treatment.

ADAS-Cog (Alzheimer’s Disease Assessment Scale-Cognitive Subscale) is a standard test for assessing changes in cognition in Alzheimer’s studies. NPI (Neuropsychiatric Inventory) is a widely used tool for measuring changes in dementia-related behavior. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function in the elderly. The interim analysis shows mean baseline values ​​of 15.5 for ADAS-Cog11, 4.5 for NPI and 22.1 for MMSE.

A large part of the value of the open study is to collect data to determine the long-term safety profile of to support simufilam in patients. Intermediate efficacy data from an open-label study have limitations compared to efficacy data from a fully completed, large, randomized, controlled clinical trial or from a fully-included open-label study. However, previous clinical research by other sponsors on Alzheimer’s disease can serve as a context reference for estimates of an expected decrease in cognition in placebo patients:

In 2019, a randomized controlled trial of aducanumab (Biogen) was carried out in> 1,000 patients with Alzheimer’s disease. In this phase 3 study (EMERGE), placebo patients taking ADAS-Cog13 showed a mean decrease in cognition of approx. 1.4 points. This corresponds to a decrease of 6.3% from the initial value up to the 6th Month. The mean ADAS-Cog13 baseline was 22.2%. The mean baseline MMSE was 26.4.

A randomized controlled study with ARICPET® (Donepezil, Eisai) was conducted in> 400 patients with mild to moderate Alzheimer’s disease.3 In this phase 3 study patients showed under placebo a mean decrease in cognition under ADAS- by about 1.9 points. Cog, a 7.3% decrease from baseline by week 24. The mean baseline ADAS-Cog was 26. The MMSE range was 10-26. Next Steps Cassava Sciences believes that today’s data and previous clinical results will advance simufilam into a Phase 3 clinical program support with Alzheimer’s. The initiation of a phase 3 study is still on schedule for the second half of 2021.

Cassava Sciences and the US Food and Drug Administration (FDA) recently held a successful meeting at the end of phase 2 (EOP2 ) for the Simufilam drug development program. Details of the EOP2 meeting will be announced in the first quarter of 2021 after the official minutes of the FDA meeting are finalized.

Based on today’s results and incoming demand from Alzheimer’s patients and their caregivers, the admission target for the open Study increased by up to 50 additional patients to a total target of approximately 150 patients. The company is currently in discussions with its scientific and clinical advisors about further possible improvements to the open label program.

About Alzheimer’s Disease Alzheimer’s disease is a progressive disorder of the brain that destroys memory and the ability to think. There are currently no drug therapies to stop Alzheimer’s disease, let alone reverse its course. In the US alone, there are currently about 5.8 million people living with Alzheimer’s disease, and in 2019, about 487,000 people aged 65 and over developed Alzheimer’s.4 The number of people with Alzheimer’s disease is expected to increase dramatically in the coming years, leading to an increase will lead to social and economic stress.5About SimufilamSimufilam is a proprietary, low molecular weight (oral) drug that restores the normal form and function of altered filamin A (FLNA), a scaffold protein, in the brain. An altered FLNA in the brain disrupts the normal function of neurons and leads to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for Simufilam is published in journals including the Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation, and Journal of Prevention of Alzheimer’s Disease.

Cassava Sciences is also developing a pre-screening diagnostic called SavaDx to detect Alzheimer’s disease with a simple blood test.

Simufilam and SavaDx were both developed in-house. Both product candidates are funded primarily through peer-reviewed research grants from the National Institutes of Health (NIH). Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease and related technologies, with no royalties to third parties.

About Cassava Sciences, Inc. Cassava Sciences’ mission is to innovate in chronic neurodegenerative diseases discover and develop. For the past 10 years, Cassava Sciences has combined cutting-edge technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. For more information, please visit: https://www.CassavaSciences.com

Cassava Sciences’ open-label study of simufilam in Alzheimer’s is funded by the National Institutes of Health (NIH / NIA) Clinical Research Grant # AG065152.

The contents of this press release are the sole responsibility of Cassava Sciences and do not necessarily represent the official views of the NIH / NIA.

Safe Harbor by Cassava SciencesThis press release contains forward-looking statements, including statements made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that address: our strategy and plans; the treatment of Alzheimer’s disease; the status of current and future clinical studies with simufilam, including the interpretation of an interim analysis of open study results; inherent limitations of the ADAS-Cog and NPI test batteries; planned enrollment and other changes to the open label program; our intention to initiate a clinical phase 3 program with simufilam in the second half of 2021; Results of our EOP2 meeting with the FDA and the timing of further announcements; oral comments from our staff; and, if applicable, potential advantages of our product candidates. These statements may be identified by words such as « may, » « anticipate, » « believe, » « could, » « expect, » « forecast, » « intend, » « plan, » « possible, » « potentially, » and « identified » there will be other words and terms of similar meaning. There is a high level of risk involved in drug development and commercialization and few research and development programs result in commercialization of a product. Our clinical results from previous clinical studies may not indicate complete results or results from later or larger clinical studies and do not warrant regulatory approval. You should not place undue reliance on these statements or scientific data that we present or publish.

Such statements are based largely on our current expectations and projections of future events. Such statements speak only as of the date of this press release and are subject to a number of risks, uncertainties, and assumptions including, but not limited to, the risks associated with the ability to conduct or complete clinical trials on anticipated schedules to demonstrate the specificity, safety, The effectiveness or potential health benefits of our product candidates, the severity and duration of healthcare precautions in the face of the COVID-19 pandemic, any unexpected impact the pandemic has on our business operations, and including those in the « Risk Factors » section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and future reports to be filed with the SEC. The foregoing identifies many, but not all, of the factors that could cause actual results to differ from those anticipated in any forward-looking statement. Given these risks, uncertainties, and assumptions, the forward-looking statements and events discussed in this press release are inherently uncertain and cannot occur. Actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely on forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this press release. Investors can find more information about these and other risks associated with our business in our filings with the SEC, which are available on the SEC’s website at www.sec.gov.

This press release may also contain statistical and drug information. based on independent industry publications or other publicly available information. We have not independently verified the accuracy or completeness of the data contained in these publicly available data and information sources. Accordingly, we do not make any representations regarding the correctness or completeness of such data or information. You are advised not to give excessive weight to such data.

1 Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf (2018) 2Source: Biogen, EMERGE Phase III study, slide 24, https://investors.biogen .com / static-files / 8e58afa4-ba37-4250-9a78-2ecfb63b1dcb (2020) 3Source: https://www.accessdata.fda.gov / drugsatfda_docs / label / 2018 / 020690s042,021720s014,022568s011lbl, 5 Source: Alzheimer’s Association. Disease facts and figures. https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf

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