Cassava ends Alzheimer’s program after simufilam fails again

26 March 2025

US biotech Cassava Sciences (Nasdaq: SAVA) will shut down development of its lead Alzheimer’s disease candidate, simufilam, after the treatment failed a second late-stage trial.

Top-line results from the Phase III REFOCUS-ALZ study showed no difference between simufilam and placebo on both co-primary endpoints - changes in cognition and function - as assessed by the ADAS-COG12 and ADCS-ADL rating scales. The trial also missed all secondary and exploratory biomarker goals.

Cassava discontinued the REFOCUS-ALZ study in late 2024 after its other pivotal trial, RETHINK-ALZ, also failed to meet its main endpoints. Still, most patients in REFOCUS-ALZ completed their final visits prior to the termination.

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