- First Phase 3 Study is Initiated to Evaluate Safety and Efficacy of Simufilam Over 52 Weeks in 750 Patients with Alzheimer’s Disease
- A Second Phase 3 Study, Expected to Begin by Year End, Will Evaluate Simufilam Over 78 Weeks In 1,000 Patients with Alzheimer’s Disease
AUSTIN, Texas, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, announced today it has initiated an initial Phase 3 efficacy study of simufilam, the Company’s investigational drug for patients with Alzheimer’s disease. A second Phase 3 efficacy study of simufilam in Alzheimer’s disease is expected to begin by year end.
Cassava Sciences’ Phase 3 efficacy studies of simufilam in Alzheimer’s disease are being conducted under Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration (FDA). The SPAs document that FDA has reviewed and agreed upon the key design features of Cassava Sciences’ Phase 3 study protocols.
“Alzheimer’s disease can have a devastating impact on patients, their families and caregivers,” said Remi Barbier, President & CEO. “We believe existing drug solutions for Alzheimer’s have limitations, and new solutions are very much needed. Our Phase 3 studies are designed to evaluate the safety and efficacy of simufilam in people with Alzheimer’s disease.”
Cassava Sciences is developing simufilam in accordance with high ethical standards and sound scientific principles. Cassava Sciences is committed to transparency and sharing information related to its Phase 3 program – for clinical protocol details, including patient eligibility, please visit: https://ClinicalTrials.gov/ct2/show/NCT04994483.
About The First Phase 3 Study (RETHINK-ALZ) The first Phase 3 study, called RETHINK-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing cognitive and functional decline over 52 weeks. Secondary objectives include the assessment of simufilam's effect on neuropsychiatric symptoms and caregiver burden. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease in the U.S. and Canada and, eventually, overseas.
About The Second Phase 3 Study (REFOCUS-ALZ) The second Phase 3 study, called REFOCUS-ALZ, which is expected to begin by year end, is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 78 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease in the U.S. and Canada and, eventually, overseas.
About Simufilam Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease. 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.
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