Cassava Sciences Announces Positive Interim Safety Review of Simufilam On-going Phase 3 Trials in Patients with Alzheimer’s Disease

• An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Simufilam in On-Going Phase 3 Clinical Trials.
  
  
• The DSMB Recommended the Phase 3 Trials of Simufilam Continue as Planned, Without Modification

AUSTIN, Texas, Sept. 18, 2023 (GLOBE NEWSWIRE) --  Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today 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.

“I think this first interim safety review is an important milestone for the clinical development of simufilam,” said Remi Barbier. “I find it very encouraging. We look forward to announcing the completion of patient enrollment for both Phase 3 studies this year.”

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.

On-going Phase 3 Studies with Simufilam
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.

About Simufilam
Simufilam is Cassava Sciences’ proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain.

Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

About Cassava Sciences, Inc.
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.