Cassava Sciences announces top-line results of 12-month interim analysis from open-label study evaluating simufilam in Alzheimer’s disease.

In a study funded by the National Institutes of Health (NIH), ADAS-Cog11 scores improved an average of 3.2 points from baseline (p<0.001) in the first 50 study subjects who completed 12 months of open-label treatment with simufilam. to emphasize impartiality, changes in adas-cog scores baseline to month 12 were independently analyzed by two consulting biostatisticians.></0.001)>

Response Analysis ;: In the first 50 study subjects who completed 12 months of open-label treatment with simufilam: i. ADAS-Cog11 scores improved an average of 3.2 points from baseline (S.D. ± 6.3; p<0.001). ii. 68% of study subjects improved on adas-cog at 12 months; these study subjects improved an average of 6.8 points (s.d. ± 3.8). iii an additional 20% of study subjects declined less than 5 points on adas-cog at 12 months; these study subjects declined an average of 2.5 points (s.d. ± 1.3).></0.001).>

An independent, published meta-analysis of patients with mild-to-moderate Alzheimer’s disease reports an average decline of 5.5 points over 12 months amongst study subjects who were administered placebo in randomized, controlled trials. Study subjects entered the open-label study with a clinical diagnosis of mild-to-moderate Alzheimer’s, Mini-Mental State Examination (MMSE) range 16-26.

Safety Analysis : Drug is well-tolerated. There are no drug-related serious adverse events through the 12-month interim analysis.