Cassava Sciences Completes Enrollment for Pivotal Phase 3 Program of Simufilam in Alzheimer’s Disease
- 1,929 patients randomized in a pair of Phase 3 trials to evaluate oral simufilam in Alzheimer's disease dementia.
- Top-line results for on-going, 52-week Phase 3 trial expected approximately year-end 2024.
- Top-line results for on-going, 76-week Phase 3 trial expected approximately mid-year 2025.
Simufilam is Cassava Sciences’ proprietary oral drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer’s achieve better health outcomes.
“We completed target enrollment for our Phase 3 program in approximately two years,” said
A total of 1,929 patients were randomized in two on-going Phase 3 trials of simufilam. These are registrational studies (aka, pivotal), meaning if positive data and results are generated, they can support the filing of a new drug application (NDA) for simufilam in Alzheimer’s disease. Both Phase 3 studies received a Special Protocol Assessment (SPA) from the FDA.
The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this study, as announced in
The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this study. Top-line results for the 76-week Phase 3 study 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
Today’s news follows recently announced interim safety MRI data that suggests simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA). In addition, a
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Cautionary Note Regarding Forward-Looking Statements:
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, relating to: our current expectations regarding timing of data and results for our on-going Phase 3 clinical trials; the design, scope, conduct, continuation, completion, intended purpose, or future results of our on-going Phase 3 program of simufilam in patients with Alzheimer's disease; the suitability of clinical data from our Phase 3 program to support the filing of an NDA; any findings or recommendations by the DSMB relating to the interim safety of simufilam in our on-going Phase 3 clinical trials; interim MRI safety data for the Phase 3 program, including ARIA; the risk of current or future findings of treatment-emergent ARIA in our clinical program of simufilam; the treatment of patients with Alzheimer’s disease dementia; comments made by our employees regarding simufilam, drug effect, safety, and the treatment of Alzheimer’s disease; the continued development of simufilam; and potential benefits, if any, of our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “look forward,” “would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and other words, phrases, and terms of similar meaning.
Simufilam is our investigational product candidate. Its safety, efficacy or science has not reviewed or approved by any regulatory authority in any jurisdiction and its desirable clinical attributes, if any, have not been established in patients.
Drug development involves a high degree of risk, and only a small number of research and development programs result in regulatory approval and commercialization of a product. Clinical results from our prior studies may not be indicative of results of future 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 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 or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, any unanticipated impacts of inflation 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
Source: Cassava Sciences, Inc.