India, March 25 -- Cassava Sciences, Inc. (SAVA), Tuesday announced that the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer's disease failed to meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints.
REFOCUS-ALZ enrolled 1,125 patients and was discontinued on November 25, 2024, following the report that a prior 52-week Phase 3 study, RETHINK-ALZ, did not meet its co-primary endpoints.
The findings revealed that Simufilam did not show a significant reduction in co-primary endpoints of cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer's disease
However, Simufilam continued to demonstrate an overall favorable safety profile
CEO Rick Barry confir...