Cassava Sciences (NASDAQ: SAVA) announced that its Phase 3 REFOCUS-ALZ study of simufilam for mild-to-moderate Alzheimer's disease failed to meet its primary endpoints. The trial, involving 1,125 patients, showed no significant reduction in cognitive or functional decline compared to placebo over 76 weeks.
The study was discontinued on November 25, 2024, following similar negative results from another Phase 3 trial, RETHINK-ALZ. While simufilam demonstrated a favorable safety profile, Cassava will completely discontinue its Alzheimer's disease development program by Q2 2025.
The company plans to redirect efforts toward evaluating simufilam for TSC-related epilepsy in preclinical studies. As of December 31, 2024, Cassava maintains a strong financial position with approximately $128.6 million in cash and cash equivalents.
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