Cassava Sciences simufilam Phase 3 Alzheimer's trial misses all endpoints; studies halted

FILANA THERAPEUTICS, INC.

Simufilam failed to meet co-primary endpoints: ADAS-COG12 delta -0.39 (p=0.43), ADCS-ADL delta 0.51 (p=0.40).
Company discontinues Phase 3 ReFocus-ALZ and open-label extension studies due to failed ReThink-ALZ results.
Simufilam showed favorable safety profile; serious AEs 13.0% vs 9.0% placebo; 1 death vs 3 in placebo.
Cash and equivalents approx $149M as of Q3 2024; company to evaluate next steps and present data at medical meeting.
Patient demographics balanced; mild-to-moderate AD enrollment; placebo decline less pronounced than expected.

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