Cassava Sciences, Inc. Announces Positive Cognition Data with Simufilam in Alzheimer’s Disease
July 29, 2021 at 09:53 am EDT
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Cassava Sciences, Inc. announced positive clinical data 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. 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 literature. 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. 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.
Cassava Sciences, Inc. is a biotechnology company focused on Alzheimer's disease. The Company's science is based on stabilizing, but not removing, a critical protein in the brain. The Company is focused on its product discovery and development efforts on disorders of the nervous system. Its lead therapeutic drug candidate, simufilam, is under clinical evaluation for the proposed treatment of Alzheimer's disease dementia in Phase 3 clinical studies. The Company has two biopharmaceutical assets under development. Its lead therapeutic product candidate, called simufilam, is an oral treatment for Alzheimer's disease dementia. Its lead investigational diagnostic product candidate, called SavaDx, is a way to detect the presence of Alzheimer's disease from a small sample of blood. Simufilam targets an altered form of a protein called filamin A in the Alzheimer's brain. It owns rights to its drug and diagnostic assets and related technologies, without royalty obligations to any third party.