Cassava Sciences Announces Completion of an Interim Safety Review of Oral Simufilam On-going Phase 3 Trials

• An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials.

• The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification.

• Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program.
  

AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of another 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’ on-going Phase 3 studies continue as planned, without modification.

“This interim safety review is yet another milestone for the clinical development of simufilam,” said Remi Barbier, President & CEO. “I find it encouraging and look forward to the final clinical safety dataset, which we expect at the conclusion of the Phase 3 program. We also look forward to announcing top-line efficacy data for our 12-month Phase 3 study late 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.

On-going Phase 3 Studies with Simufilam
Cassava Sciences’ simufilam is a novel, small molecule drug candidate for the proposed treatment of Alzheimer’s disease dementia. The drug is in late-stage clinical evaluation in a pair of pivotal Phase 3 trials. These Phase 3 trials are fully enrolled. Over 1,900 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria are randomized into the trials.

The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this trial, as announced in October 2023. Top-line results for the 52-week Phase 3 trial are currently expected approximately year-end 2024.

The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this trial, as announced in November 2023. Top-line results for the 76-week Phase 3 trial 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 (CRO).