Cassava Sciences completes patient enrollment for Phase 3 program of simufilam

Cassava Sciences announced the completion of patient enrollment in a pair of Phase 3 trials to evaluate the safety and efficacy of oral simufilam versus placebo in Alzheimer’s disease dementia. Simufilam is Cassava Sciences’ proprietary oral drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes. A total of 1,929 patients were randomized in two on-going Phase 3 trials of simufilam. These are registrational studies, meaning if positive data and results are generated, they can support the filing of a new drug application for simufilam in Alzheimer’s disease. Both Phase 3 studies received a Special Protocol Assessment from the FDA. The first Phase 3 trial has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this study, as announced in October 2023. Top-line results for the 52-week Phase 3 study are currently expected approximately year-end 2024. The second Phase 3 trial has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this study. Top-line results for the 76-week Phase 3 study are currently expected approximately mid-year 2025. Patients with mild-to-moderate Alzheimer’s disease dementia who met study eligibility criteria were recruited into the Phase 3 program from clinical sites in the U.S., Puerto Rico, Canada, Australia and South Korea. Cassava Sciences is conducting its on-going Phase 3 program in collaboration with Premier Research International, a global contract research organization/