Cassava Sciences One Step Closer to Alzheimer’s Disease Treatment
Cassava Sciences, Inc. (Nasdaq: SAVA) has announced a positive interim safety review of its lead candidate, simufilam currently under evaluation in patients with Alzheimer’s disease. An independent Data and Safety Monitoring Board recommended that Cassava’s Phase 3 studies continue as planned, without modification.
Chairman of the Board, President & CEO of Cassava, Remi Barbier, said, “…This first interim safety review is an important milestone for the clinical development of simufilam. I find it very encouraging. We look forward to announcing the completion of patient enrollment for both Phase 3 studies this year.”
Cassava’s Phase 3 studies have received a Special Protocol Assessment (SPA) from the FDA.
Cassava Sciences is evaluating simufilam oral tablets for Alzheimer’s disease dementia in two global Phase 3 clinical studies.
The studies are randomized, double-blind, placebo-controlled trials expected to enroll approximately 1,750 patients with mild-to-moderate Alzheimer’s disease.
Patient enrollment is expected to be completed for both Phase 3 studies by the end of 2023.
Simufilam is a proprietary, oral drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain.
About Cassava Sciences
Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Our product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established in humans.