Cassava Sciences Inc. (NASDAQ: SAVA) has announced top-line clinical study data from its pre-planned interim analysis of the ongoing open-label trial with simufilam in mid-to-moderate Alzheimer’s disease patients.
Simufilam study supported by NIH
ADAS-Cog11 scores improved at a mean of 3.2 points from baseline in the first 50 trial individuals who completed the twelve-month open-label treatment with simufilam, according to a study supported by the National Institutes of Health (NIH). In addition, two consulting biostatisticians independently assessed changes in ADAS-Cog scores from baseline to month 12 to ensure impartiality.
CEO & President Remi Barbier said, “I feel energized and encouraged by the clinical data. We look forward to the initiation of a randomized, double-blind, placebo-controlled pivotal Phase 3 clinical program with simufilam in people with Alzheimer’s disease.”
Anxiety, agitation, and delusions are common behavioral disorders associated with Alzheimer’s disease. As the condition progresses, these may become increasingly common. The Neuropsychiatric Inventory (NPI) is a commonly used clinical instrument for assessing changes in dementia-related behavior. On the NPI, 34% of the study participants had no neuropsychiatric symptoms at the start. More than half of the participants had no neuropsychiatric symptoms after a year.
Cassava has enrolled 200 subjects in the study
The company began a long-term, open-label trial in March 2020 to test simufilam in Alzheimer’s disease patients. The NIH provided funding for this research. The open-label trial will track the long-term tolerability and safety of simufilam 100mg given twice daily for 12 months or longer. About 200 study subjects were enrolled from 16 investigator sites across the United States and Canada in the open-label study.
Cassava Sciences is testing Simufilam in a third phase Alzheimer’s disease clinical trial. The start of the study is scheduled for Q4 of 2021. On August 24, 2021, the company stated that it had secured an agreement with the FD) for both of its Phase 3 investigations under a Special Protocol Assessment (SPA).