Alzheimer's Treatment: Cassava Sciences' Simufilam Slows Cognitive Decline by 38% in Clinical Study

Cassava Sciences Inc SAVA announced topline clinical results from its Cognition Maintenance Study (CMS), a small proof-of-concept study designed to demonstrate the effects of simufilam versus placebo in a randomized withdrawal trial design.

The study enrolled 157 patients with mild-to-moderate Alzheimer's disease.

Simufilam treatment for six months slowed cognitive decline by 38% compared to placebo in mild-to-moderate Alzheimer's disease (MMSE 16-26). 

The placebo arm declined 1.5 points on ADAS-Cog. The simufilam arm declined 0.9 points, a 38% difference in favor of the drug.

Upon randomization into the CMS, mean baseline MMSE scores were 18.6 and 18.1 for the simufilam and placebo arms, with mean baseline ADAS-Cog scores of 19.3 and 21.9, respectively.

Simufilam treatment slowed cognitive decline > 200% compared to placebo in mild Alzheimer's disease. 

CMS patients with mild Alzheimer's (MMSE 21-26) on placebo declined 0.6 points on ADAS-Cog, while patients on simufilam improved 0.6 points, a 205% difference in favor of the drug.

Mild patients randomized to simufilam in the CMS showed no material decline in ADAS-Cog scores over 18 months, indicating stable cognition, whereas the placebo declined by 0.8 points.

Simufilam 100 mg twice daily was safe and well tolerated in this study. There were no drug-related serious adverse events. 

Cassava Sciences is currently evaluating simufilam tablets for Alzheimer's disease dementia in two Phase 3 studies. Patient enrollment is expected to be completed for Phase 3 studies by year-end 2023.

Earlier this year, Cassava Sciences announced topline Phase 2 results for simufilam for Alzheimer's dementia. 

Price Action: SAVA shares are down 12.90% at $22.05 on the last check Wednesday.