Cassava Sciences Provides Mid-Year Corporate Update, Clinical Development Progress and Announces Guidance on Clinical Data Release
- Open-label Study Completes Patient Enrollment
- Cognition Maintenance Study Initiated
May 2020, now 30% Enrolled
- 6-month Biomarker Data to be Presented at
AAIC Conferencein July
- 9-month Safety & Cognition Data to be Presented at
- Clinical Results with SavaDx to be Presented at
- Phase 3 Program Initiation Remains On-track for 2nd Half 2021
“Patients with Alzheimer’s want clear and present evidence of drug efficacy,” said
Clinical progress across Cassava Sciences’ product portfolio is summarized below.
Update on Open-label Study with Simufilam
The open-label study has completed its target enrollment of 150 subjects. By physician and patient request, clinical sites may continue to enroll additional subjects up through the initiation of the Company’s Phase 3 pivotal program of simufilam.
Guidance on Clinical Data Release
- Biomarkers of Alzheimer’s disease: amyloid beta42, total tau, P-tau181.
- Biomarkers of neurodegeneration: neurogranin, neurofilament light chain (NfL).
- Biomarkers of neuroinflammation: YKL-40, sTREM2 and HMGB1.
Biomarker data were analyzed from cerebrospinal fluid (CSF) collected from twenty-five study subjects who underwent a small volume lumbar puncture at baseline and again after completing 6 months of open-label drug treatment.
Update on the Cognition Maintenance Study (CMS)
Update on the Phase 3 Clinical Program
Cassava Sciences’ Phase 3 program consists of two double-blind, randomized, placebo-controlled studies in patients with mild-to-moderate Alzheimer’s disease.
The first Phase 3 study is designed to evaluate symptomatic improvement in Alzheimer’s disease. The goal is to demonstrate improved cognition and daily function in subjects treated with simufilam compared to baseline and to placebo. Approximately 600 subjects will be enrolled, randomized (1:1) to simufilam 100 mg or placebo BID, and treated for 12 months. Efficacy endpoints are ADAS-Cog, a cognitive scale, and ADCS-ADL, a scale of daily function.
The second Phase 3 study is designed to evaluate disease-modifying effects of simufilam in Alzheimer’s disease. The goal is to demonstrate a slower rate of decline in cognition and daily function in subjects treated with simufilam compared to placebo. Approximately 1,000 subjects will be enrolled, randomized (1:1:1) to simufilam 100 mg, 50 mg or placebo BID, and treated for 18 months. Efficacy endpoints are ADAS-Cog and ADCS-ADL.
Update on SavaDx
SavaDx is an investigational diagnostic candidate to detect Alzheimer’s disease with a simple blood test. SavaDx was evaluated for its ability to detect treatment effects of simufilam versus placebo in a randomized, controlled study completed in 2020. This was a Phase 2b study that enrolled 64 patients with Alzheimer’s disease. The SavaDx clinical dataset will be presented at AAIC the week of
Update on Corporate Outlook
In addition, in
Net cash use for operations for full-year 2021 is still expected to be approximately
To support current and future expected clinical progress,
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding 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
SavaDx is Cassava Sciences’ investigational diagnostic to detect Alzheimer’s disease. The goal of SavaDx is to make the detection of Alzheimer’s as simple as getting a blood test, possibly years before the appearance of any overt clinical symptoms. SavaDx is substantially funded by a peer-reviewed research grant award from the
Simufilam and SavaDx were both developed in-house.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course.
As of 2020, there were approximately 50 million people worldwide living with dementia, a figure expected to increase to 150 million by 2050.1 The annual global cost of dementia is now above $1 trillion, according to Alzheimer’s
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 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: the Company’s anticipated data presentations at AAIC; expectations regarding convergence of biomarker and cognition data, and treatment benefits of simufilam; the Company’s execution on its strategy to initiate a Phase 3 clinical program in Alzheimer’s disease in 2021; expected cash use in future periods and ability of existing cash to support the Phase 3 clinical development program of simufilam; planned growth in personnel and facilities; and Mr. Barry’s anticipated contributions to the Board of Directors. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning.
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 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, 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
For further information regarding these and other risks related to our business, investors should consult our filings with the
Source: Cassava Sciences, Inc.