No Decline in Cognition Scores in Patients with Mild Alzheimer's Disease Who Received Simufilam Continuously For 24 Months - Seite 3

We expect to report data from the two-year clinical safety study in a science forum.

Prior Results
Top-line results of the 6-month randomized withdrawal phase (i.e., the Cognition Maintenance Study) were announced July 5, 2023. Please see: https://www.cassavasciences.com/news-releases/news-release-details/ora ...

Top-line results of the 12-month open-label phase were announced on January 24, 2023. Please see: https://www.cassavasciences.com/news-releases/news-release-details/cas ...

Study Limitations
Data results from our two-year open-label safety study, or any phase thereof, do not constitute, and should not be interpreted as, regulatory evidence of safety or efficacy for simufilam in Alzheimer’s disease dementia. Rigorous evidence for drug safety and efficacy is derived from one or more large, randomized, placebo-controlled studies. The open-label design and limited size of this study, and each sub-group of this study, may introduce clinical or statistical bias or may generate results that may not fully distinguish between drug effects and random variation. In addition, we do not know how long a washout period may be needed to remove lingering drug effects, if any, from prior treatment with open-label simufilam. Different methods of statistical analysis of clinical data from the same study may lead to objectively different numerical results. These and other statistical and clinical features of our open-label study add complexity or limitations to the scope of data interpretation.

‘Top-line data’ is a summary of the clinical data prior to the completion of a full and final audit or quality-control of the clinical database. We are communicating top-line data so that stakeholders may have timely access to a summary of the open-label study findings prior to us receiving the final dataset. Final data may change from top-line data.

On-going Phase 3 Studies of Simufilam in Alzheimer’s Disease
Cassava Sciences is evaluating oral simufilam for Alzheimer’s disease dementia in two global Phase 3 clinical studies, both of which are fully enrolled. A total of 1,929 patients with mild-to-moderate Alzheimer’s disease dementia who met study eligibility criteria were randomized into the Phase 3 program from sites in the U.S., Puerto Rico, Canada, Australia and South Korea.