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, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of a third 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) resulted in a recommendation that both of Cassava Sciences’ on-going Phase 3 studies continue as planned, without modification.

“We are pleased to have satisfactorily completed this safety review, the last before the expected top-line read out for our first Phase 3 study.” said Jim Kupiec, Chief Medical Officer. “We look forward to announcing top-line efficacy, safety and biomarker data for our 12-month Phase 3 study before the end of 2024.”

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 met other study eligibility criteria were 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. Top-line results for the 52-week Phase 3 trial are currently expected by 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. 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).

Today’s news follows interim safety MRI data announced in October 2023, which suggests simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA). In addition, September 2023 and March 2024 meetings of the DSMB recommended that both Phase 3 trials continue as planned, without modification. Final safety data are expected at the conclusion of the Phase 3 program.

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.

Simufilam is Cassava Sciences’ small molecule oral drug candidate currently in Phase 3 clinical trials for the treatment of Alzheimer's disease. Simufilam targets a specific site on filamin A, a scaffolding protein that is critical to certain receptor interactions in the brain. Cassava Sciences believes that simufilam interrupts amyloid-β42 binding to receptors in the brain and may affect the Alzheimer's disease process. Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party.

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Cautionary Note Regarding Forward-Looking Statements and Other Notices:

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning.

Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct, complete or announce top-line results of our clinical studies, including efficacy, safety and biomarker data, on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates in people with Alzheimer’s disease dementia; the interim safety status or profile of simufilam to date in our Phase 3 clinical studies; our current expectations regarding timing of clinical data for our Phase 3 studies; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; verbal comments made by our employees regarding simufilam, safety, drug effects, and the treatment of Alzheimer’s disease with simufilam; potential benefits, if any, of our product candidates and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the period ended June 30, 2024, and future reports to be filed with the SEC.

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