Cassava Sciences Initiates a Phase 3 Efficacy Trial of Simufilam for the Treatment of Patients with Alzheimer’s Disease
- 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
Cassava Sciences’ Phase 3 efficacy studies of simufilam in Alzheimer’s disease are being conducted under Special Protocol Assessments (SPA) from the
“Alzheimer’s disease can have a devastating impact on patients, their families and caregivers,” said
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
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
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
Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years,
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Cautionary Note Regarding Forward-Looking Statements: This press release includes forward looking statements including but not limited to those regarding the timing of the initiation of a second Phase 3 study with simufilam in Alzheimer’s disease by year end, the number of participants we expect to enroll in our Phase 3 studies, the geographic areas for study enrollment, the expected treatment benefits of simufilam for people with Alzheimer’s disease and oral or written comments made by our employees regarding simufilam and its clinical development.
Drug development involves a high degree of risk, and historically only a small number of research and development programs result in commercialization of a product. Clinical results from our earlier-stage clinical trials may not be indicative of full results or results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. Such statements are based 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 initiation, conduct or completion of our clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our business operations, and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended
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Source: Cassava Sciences, Inc.