Cassava Sciences, Inc. (NASDAQ: SAVA) announced a business update, including a workforce reduction and the expected timeline for topline data from its REFOCUS-ALZ study. The company, focused on developing treatments for central nervous system diseases, including Alzheimer's disease dementia, is implementing cost curtailment measures after a Phase 3 trial setback.
Simufilam's REFOCUS-ALZ Study Data Anticipated
Cassava Sciences anticipates releasing topline data from its Phase 3 REFOCUS-ALZ study in late first-quarter or early second-quarter 2025. The REFOCUS-ALZ trial is a multi-center, double-blinded, placebo-controlled, randomized study designed to evaluate the safety and efficacy of two doses of simufilam in patients with mild-to-moderate Alzheimer's disease. Approximately 1,125 participants were randomized to receive either 50 mg or 100 mg of simufilam, or a matched placebo, administered orally twice daily for 76 weeks.
The co-primary endpoints of the REFOCUS-ALZ study include assessing changes in cognition and function from baseline to week 76 using the ADAS-COG12 and ADCS-ADL scales. Secondary endpoints encompass measures of neuropsychiatric symptoms and caregiver burden. The study also incorporates evaluations of plasma and cerebrospinal fluid biomarkers, including P-tau181, P-tau217, and neurofilament light chain, alongside brain volume assessments via MRI and amyloid and tau deposition via PET scans.
Cost Reduction Measures
In light of the RETHINK-ALZ study not meeting its co-primary endpoints, Cassava Sciences is reducing its workforce by approximately 33%, affecting 10 employees, in the first quarter of 2025. This action is part of a broader strategic expense management effort, which includes halting planned biomarker analysis of additional plasma samples from prior Phase 2 studies. The company estimates incurring approximately $0.4 million in one-time costs in Q1 2025 related to the workforce reduction.
As of December 31, 2024, Cassava Sciences reported unaudited cash and cash equivalents of approximately $128.6 million.
RETHINK-ALZ Study Outcome
In November 2024, Cassava Sciences announced that topline results from the Phase 3 RETHINK-ALZ study, which evaluated simufilam in patients with mild-to-moderate Alzheimer’s disease, did not meet its prespecified co-primary endpoints. The company intends to share a detailed analysis of the data from this study at a future medical meeting.
RETHINK-ALZ (NCT04994483) randomized 804 patients with confirmed mild or moderate Alzheimer’s disease to receive either a 100 mg tablet of simufilam (n=403) or a matched placebo (n=401), dosed orally twice daily (BID) for 52 weeks. The co-primary endpoints for this study included the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo.
Leadership Perspective
"Cassava continues to be dedicated to its mission of developing novel medicines for central nervous system disorders and enhancing shareholder value," said Rick Barry, President and Chief Executive Officer. "We are in the final stages of discontinuing the REFOCUS-ALZ study and expect to report topline results late first-quarter/early second-quarter 2025. In addition, we continue to carefully review the data from the RETHINK-ALZ study and plan to incorporate the results of the REFOCUS-ALZ study into our evaluation of next steps for Cassava."
