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Outside Biostatisticians with Specific Expertise in Alzheimer’s Disease Will Conduct an Independent Statistical Analysis on The Clinical Dataset.
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Clinical Dataset May Be Announced Approximately Year-End 2022, Pending Completion of Study Report by Outside Biostatisticians.
AUSTIN, Texas, Dec. 06, 2022 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology firm, in the present day introduced the completion of drug administration in an open-label examine of simufilam for Alzheimer’s illness. This examine was designed to guage long-term drug security and to measure cognitive adjustments (ADAS-cog) over 12 months in roughly 200 sufferers with mild-to-moderate Alzheimer’s illness handled with open-label simufilam 100 mg twice day by day. Simufilam is Cassava Sciences’ oral drug candidate for Alzheimer’s illness dementia.
To guarantee the very best integrity of information evaluation, outdoors biostatisticians with particular experience in Alzheimer’s illness will conduct an impartial statistical evaluation on the scientific dataset. Cassava Sciences could announce examine outcomes roughly year-end 2022, pending completion of a examine report by outdoors biostatisticians.
“We are thrilled with the progress made to date in the clinical development of simufilam, our oral drug candidate for people with Alzheimer’s disease,” stated Remi Barbier, President & CEO. “We applaud recent clinical advances with anti-amyloid antibody drugs for Alzheimer’s, but these may not be enough. I think innovations are needed around new targets, new molecules, drug safety and dosing. I believe Cassava Sciences may be at the forefront of this effort to innovate.”
Overview of On-going Phase 3 Clinical Program
Cassava Sciences is evaluating simufilam for Alzheimer’s illness dementia in two Phase 3 scientific research. Both research have acquired a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. Over 750 sufferers at the moment are enrolled within the Phase 3 program.
Cassava Sciences’ RETHINK-ALZ Phase 3 examine is designed to guage the protection and efficacy of oral simufilam 100 mg in enhancing cognition and slowing purposeful decline over 52 weeks. This randomized, double-blind, placebo-controlled examine plans to enroll roughly 750 sufferers with mild-to-moderate Alzheimer’s illness. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice day by day.
Cassava Sciences’ REFOCUS-ALZ Phase 3 examine is designed to guage the protection and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled examine plans to enroll roughly 1,000 sufferers with mild-to-moderate Alzheimer’s illness. Patients are randomized (1:1:1) to simufilam 100 mg, 50 mg, or placebo twice day by day.
Both Phase 3 research have the identical co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a purposeful scale).
About Simufilam
Simufilam (sim-uh-FILL-am) is Cassava Sciences’ proprietary, small molecule (oral) drug that restores the traditional form and performance of altered filamin A (FLNA) protein within the mind. Cassava Sciences owns worldwide growth and industrial rights to its analysis applications in Alzheimer’s illness, and associated applied sciences, with out royalty obligations to any third social gathering.
About Cassava Sciences, Inc.
Cassava Sciences is a clinical-stage biotechnology firm based mostly in Austin, Texas. Our mission is to detect and deal with neurodegenerative ailments, comparable to Alzheimer’s illness. Our novel science relies on stabilizing—however not eradicating—a essential protein within the mind. Our product candidates haven’t been accepted by any regulatory authority, and their security, efficacy or different fascinating attributes haven’t been established.
For extra data, please go to: https://www.CassavaSciences.com
For More Information Contact:
Eric Schoen, Chief Financial Officer
(512) 501-2450, or eschoen@CassavaSciences.com
Cautionary Note Regarding Forward-Looking Statements: This information launch accommodates forward-looking statements, together with statements made pursuant to the secure harbor provisions of the Private Securities Litigation Reform Act of 1995, regarding: our technique and plans; expectations relating to scientific outcomes of our open-label examine of simufilam in Alzheimer’s illness; the scale or composition of affected person enrollment on this open-label examine; plans to launch scientific outcomes of our open-label examine, and the timing thereof; the therapy of Alzheimer’s illness; the timing, enrollment, period, geography and different particulars of a Phase 3 scientific program with simufilam; and potential advantages, if any, of simufilam. These statements could also be recognized by phrases comparable to “may,” “anticipate,” “believe,” “could,” “expect,” “would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and different phrases and phrases of comparable which means.
Drug growth and commercialization contain a excessive diploma of threat, and solely a small variety of analysis and growth applications lead to commercialization of a product. Our interim knowledge and evaluation shouldn’t be relied upon as predictive of full examine outcomes for any of our research. Our scientific outcomes from earlier-stage scientific trials will not be indicative of full outcomes or outcomes from later-stage or bigger scale scientific trials and don’t guarantee regulatory approval. You shouldn’t place undue reliance on these statements or any scientific knowledge we current or publish.
Such statements are based mostly largely on our present expectations and projections about future occasions. Such statements communicate solely as of the date of this information launch and are topic to numerous dangers, uncertainties and assumptions, together with, however not restricted to, these dangers regarding the flexibility to conduct or full scientific research on anticipated timelines, to show the specificity, security, efficacy or potential well being advantages of our product candidates, the severity and period of well being care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our enterprise operations, and together with these described within the part entitled “Risk Factors” in our Annual Report on Form 10-Okay for the 12 months ended December 31, 2021, and future studies to be filed with the SEC. The foregoing units forth many, however not all, of the components that might trigger precise outcomes to vary from expectations in any forward-looking assertion. In gentle of those dangers, uncertainties and assumptions, the forward-looking statements and occasions mentioned on this information launch are inherently unsure and will not happen, and precise outcomes may differ materially and adversely from these anticipated or implied within the forward-looking statements. Accordingly, you shouldn’t rely on forward-looking statements as predictions of future occasions. Except as required by regulation, we disclaim any intention or accountability for updating or revising any forward-looking statements contained on this information launch. For additional data relating to these and different dangers associated to our enterprise, traders ought to seek the advice of our filings with the SEC, which can be found on the SEC’s web site at www.sec.gov.
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