Cassava Sciences, Inc. announced a positive interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer?s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences? Phase 3 studies of simufilam continue as planned, without modification.

The DSMB is composed of independent clinical research experts who periodically review interim patient safety data for Cassava Sciences? on-going Phase 3 trials of simufilam in Alzheimer?s disease. This DSMB only reviews patient safety.

It does not assess drug efficacy. The next routine meeting of the DSMB is scheduled for March 2024. Cassava Sciences is evaluating simufilam oral tablets for Alzheimer?s disease dementia in two global Phase 3 clinical studies.

These are randomized, double-blind, placebo-controlled trials. The Phase 3 program aims to enroll a total of approximately 1,750 patients with mild-to-moderate Alzheimer?s disease who also meet other study eligibility criteria. Patient enrollment is expected to be completed for both Phase 3 studies by yearend 2023.

Both Phase 3 studies have received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration.