Cassava Sciences falls after simufilam data for Alzheimer’s disease treatment

Cassava Sciences shares are down 6.70% or $2.44 to $34 per share in pre-market trading afterannouncing positive top-line Phase 2 results for simufilam, its oral drug candidate for Alzheimer’s disease dementia. This was an open-label safety study with exploratory efficacy endpoints. The study enrolled over 200 patients with mild-to-moderate Alzheimer’s disease . Study participants were administered open-label simufilam tablets 100mg twice daily for 1 year or more. Endpoints were measured at baseline and month 12.Alzheimer’s is a degenerative disease of the brain. Over time, cognition progressively worsens in the mild-to-moderate stages of Alzheimer’s as the disease takes its toll. ADAS-Cog scores that change minimally, over 1 year is a highly desirable outcome in a clinical study of mild-to-moderate Alzheimer’s disease. Efficacy outcomes were analyzed by an independent, outside biostatistical consulting firm led by Suzanne Hendrix, PhD. The pre-specified primary efficacy endpoint was change in baseline on ADAS-Cog, a cognitive scale widely used in Alzheimer’s clinical research. Exploratory endpoints included the Mini-Mental State Examination to assess disease stage by cognitive impairment; the Neuropsychiatric Inventory to assess dementia related behavior; and the Geriatric Depression Scale . The Full Analysis Set population was used for the statistical analysis of efficacy endpoints.