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Cassava Sciences Reports Topline Phase 3 REFOCUS-ALZ Data

Cassava Sciences Reports Topline Phase 3 REFOCUS-ALZ Data

Simufilam did not show a significant reduction in co-primary endpoints of cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer's disease
Simufilam continued to demonstrate an overall favorable safety profile
Cassava's Alzheimer's disease development program with simufilam will be completely discontinued by the end of Q2 2025
AUSTIN, Texas, March 25, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, 'Cassava', the 'Company'), a clinical-stage biotechnology company focused on developing a novel, investigational treatment for central nervous system disorders, including Alzheimer's disease (AD) dementia and tuberous sclerosis complex (TSC)-related epilepsy, today shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate AD.
Topline data indicate that REFOCUS-ALZ did not meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints. The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo. REFOCUS-ALZ enrolled 1,125 patients and was discontinued on November 25, 2024, following the report that a prior 52-week Phase 3 study, RETHINK-ALZ, did not meet its co-primary endpoints. A large portion of subjects enrolled in REFOCUS-ALZ completed their final study visit prior to the termination of the trial. Simufilam continued to demonstrate an overall favorable safety profile.
'We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer's disease. These results were unambiguous. Working with patients, their families and their caregivers has brought a special dignity to our Phase 3 Alzheimer's disease clinical trial program and to each of us at Cassava. We are deeply grateful for the dedication and committed efforts of study investigators and site teams, who enabled us to conduct these trials with integrity and scientific rigor and whose efforts provided a clear data read out,' said Rick Barry, President and Chief Executive Officer of Cassava.
'Cassava will discontinue all efforts to develop simufilam for Alzheimer's disease and we expect to phase out the program by the end of Q2 2025,' continued Mr. Barry. 'We remain dedicated to our mission of developing novel medicines for central nervous system disorders. While we have initiated preclinical studies to evaluate simufilam's potential as a treatment for TSC-related epilepsy, we maintain ongoing strategic expense management efforts.'
Eric Schoen, Chief Financial Officer of Cassava commented, 'We remain focused on the interests of Cassava shareholders and are committed to enhancing shareholder value. Cassava is well-capitalized with approximately $128.6 million in cash and cash equivalents as of December 31, 2024.'
Summary Study Results:
Primary Endpoint Data
Co-Primary Endpoints
LS means change from baseline to the end of the double-blind treatment period
N=372 N=376 N=372
ADAS-COG12 (±SE) 4.97 (± 0.46) 4.70 (± 0.46) 0.27 (± 0.63) P=0.67
5.26 (± 0.46) 4.70 (± 0.46) 0.56 (± 0.63) P=0.37
N=373 N=376 N=373
ADCS-ADL (±SE) - 6.27 (± 0.57) - 5.32 (± 0.57) - 0.95 (± 0.79) P=0.23
- 6.43 (± 0.57) - 5.32 (± 0.57) - 1.10 (± 0.79) P=0.16
*Based on the intent-to-treat population
BID = twice daily
ADAS-COG12 = The Alzheimer's Disease Assessment Scale – Cognitive Subscale (a lower number represents less cognitive impairment)
ADCS-ADL = Alzheimer's Disease Cooperative Study – Activities of Daily Living (a higher number represents less functional impairment)
Safety Data:
The table below provides a high-level summary of the patient demographic and safety data. Simufilam continued to demonstrate an overall favorable safety profile.
Metrics for Simufilam and Placebo Simufilam 100 mg BID Simufilam 50 mg BID Placebo BID
Baseline*
N=374 N=376 N=375
Age, mean (SD), in years 73.6 ± 8.2 74.5 ± 7.6 73.7 ± 7.9
Sex, n (%) female 208 (55.6%) 207 (55.1%) 214 (57.1%)
MMSE Score (No.%,)
21-27 240 (64.2%) 242 (64.4%) 235 (62.7%)
16-20 134 (35.8%) 134 (35.6%) 138 (36.8%)
Race/Ethnicity
White 326 (87.2%) 326 (86.7%) 313 (83.5%)
Black 17 (4.5%) 23 (6.1%) 21 (5.6%)
Asian 28 (7.5%) 21 (5.6%) 32 (8.5%)
Other 3 (0.8%) 6 (1.6%) 9 (2.4%)
Safety**
N=374 N=376 N=373
Any Adverse Event (AE) 286 (76.5%) 288 (76.6%) 282 (75.6%)
Serious AEs 43 (11.5%) 61 (16.2%) 45 (12.1%)
Death 2 (0.5%) 6 (1.6%) 3 (0.8%)
AEs leading to discontinuation from the study 32 (8.6%) 34 (9.0%) 17 (4.6%)
Most Frequent AEs ≥ 5.0%
1: COVID-19 45 (12.0%) 49 (13.0%) 40 (10.7%)
2: Urinary Tract Infection 32 (8.6%) 41 (10.9%) 34 (9.1%)
3: Fall 32 (8.6%) 43 (11.4%) 51 (13.7%)
4: Dizziness 26 (7.0%) 11 (2.9%) 23 (6.2%)
5: Diarrhea 14 (3.7%) 19 (5.1%) 15 (4.0%)
*Based on the intent-to-treat population
**Based on the safety population
BID = twice daily
AD = Alzheimer's disease
MMSE = Mini-Mental State Examination
About REFOCUS-ALZ
REFOCUS-ALZ (NCT05026177) is a Phase 3 trial designed as a multi-center, double-blinded, placebo-controlled, randomized parallel group study to evaluate the safety and efficacy of two doses of simufilam compared to a placebo in a study involving over 75 clinical trial sites in the U.S., Canada, Puerto Rico and South Korea. The clinical trial sites that conducted REFOCUS-ALZ were completely distinct from the clinical trial sites that conducted RETHINK-ALZ. REFOCUS-ALZ randomized approximately 1,125 people utilizing the same eligibility criteria as RETHINK-ALZ. Subjects were randomized 1:1:1 to receive simufilam, dosed in 50 mg or 100 mg tablets, or a matched placebo, dosed orally twice daily (BID) for 76 weeks. On November 25, 2024, the Company announced plans to discontinue the REFOCUS-ALZ study and its intention to report topline data from that trial, including the complete 52-week dataset and a large portion of 76-week data.
The prespecified co-primary endpoints for this study included the change in cognition and function from baseline to the end of the double-blind treatment period at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing each dose of simufilam to placebo. Secondary endpoints included several well validated measures of neuropsychiatric symptoms and caregiver burden. Safety was evaluated by adverse event monitoring, as well as standard laboratory and ECG assessments. The study also included an evaluation of changes in plasma and cerebrospinal fluid biomarkers from baseline to week 76, including P-tau217 (phosphorylated tau at threonine 217), GFAP (glial fibrillary acidic protein) and NFL (neurofilament light chain), as well as an evaluation of various brain volumes using MRI (magnetic resonance imaging) and amyloid and tau deposition using PET (positron emission tomography) scans from baseline to week 76.
About Simufilam
Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein.
About Cassava Sciences, Inc.
Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system disorders, including Alzheimer's disease and tuberous sclerosis complex (TSC)-related epilepsy. Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein. The Company is based in Austin, Texas.
For More Information Contact:
Investors
Sandya von der Weid
Media
Company
Eric Schoen, Chief Financial Officer
(512) 501-2450
Cautionary Note Regarding Forward-Looking Statements:
This news release contains forward-looking statements that include but are not limited to statements regarding: REFOCUS-ALZ and RETHINK-ALZ, the timing for discontinuation of our Alzheimer's disease development program, our plans for the development of investigational treatments for central nervous system disorders, our plans to conduct preclinical studies of simufilam relating to seizures in TSC, the potential for simufilam as a treatment for TSC-related epilepsy, our strategic expense management efforts and the timing of anticipated milestones. These statements may be identified by words such as 'anticipate', 'before', 'believe', 'could', 'expect', 'forecast', 'intend', 'may', 'pending', 'plan', 'possible', 'potential', 'prepares for', 'will', and other words and terms of similar meaning.
Such statements are based 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 efficiently discontinue the Company's Alzheimer's disease development program, the ability to advance preclinical studies related to TSC-related epilepsy, and other risks inherent in drug discovery and development or specific to Cassava Sciences, Inc., as described in the section entitled 'Risk Factors' in our Annual Report on Form 10-K for the year ended December 31, 2024, and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov.
All of our pharmaceutical assets under development are investigational product candidates. They have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.
Our clinical results from earlier-stage clinical trials may not be indicative of future 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.
We are in the business of new drug discovery, development and commercialization. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery, development and commercialization, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.

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Key Topics Covered: 1 Market Guides1.1 Situation Analysis1.2 Guide for Executives and Marketing Staff1.3 Guide for Investment Analysts and Management Consultants 2 Introduction and Market Definition2.1 What are PCR Technologies?2.2 PCR and Syndromic Testing2.3 Market Definition2.4 Methodology2.5 Perspective: Healthcare and the IVD Industry2.5.1 Global Healthcare Spending2.5.2 Spending on Diagnostics2.5.3 Important Role of Insurance for Diagnostics 3 PCR - Guide to PCR Technologies3.1 Concepts3.1.1 Method3.2 Applications3.2.1 Finding Specific DNA3.2.2 Measuring DNA3.2.3 Medical and Diagnostic Applications3.2.3.1 Carrier, prenatal and tissue typing3.2.3.2 Cancer Diagnosis and Management3.2.3.3 Infectious Disease - New Levels of Accuracy and Sensitivity3.2.3.4 Forensic Applications3.2.3.5 Science and Research3.3 PCR - Advantages and Disadvantages3.4 Different Types of PCR3.4.1 Simple Changes3.4.1.1 Multiplex-PCR3.4.1.2 VNTR PCR3.4.1.3 Asymmetric PCR3.4.1.4 Long PCR3.4.1.5 Nested PCR3.4.1.6 Quantitative PCR3.4.1.7 Hot-start PCR3.4.1.8 Touchdown PCR3.4.1.9 Assembly PCR3.4.1.10 Colony PCR3.4.1.11 Suicide PCR3.4.1.12 Cold PCR3.4.2 Digital PCR3.4.2.1 Droplet Digital PCR3.4.2.2 Comparison between dPCR and Real-Time PCR (qPCR)3.4.2.3 Digital PCR in Use3.4.2.4 Digital PCR Commercial History3.4.3 Isothermal PCR 4 Industry Overview4.1 Players in a Dynamic Market4.1.1 Academic Research Lab4.1.2 Diagnostic Test Developer4.1.3 Instrumentation Supplier4.1.4 Chemical/Reagent Supplier4.1.5 Pathology Supplier4.1.6 Independent Clinical Laboratory4.1.7 Public National/regional Laboratory4.1.8 Hospital Laboratory4.1.9 Physicians Office Lab (POLS)4.1.10 Audit Body4.1.11 Certification Body 5 Market Trends5.1 Factors Driving Growth5.1.1 A New Standard5.1.2 Down the Curve We Go5.1.3 Multiplexing5.1.4 Syndromic Diagnostics Looks Unstoppable5.1.5 The Genetic Blizzard5.2 Factors Limiting Growth5.2.1 The Cost Curve5.2.2 The Other Guys5.2.3 Systemic Roadblocks5.3 Diagnostic Technology Development5.3.1 The Instrumentation Curve5.3.2 Shifting Role of Diagnostics5.3.3 Diagnostics Moves Out of the Hospital5.3.4 Disruption Looms5.3.5 The Next Five Years 6 PCR Recent Developments6.1 Recent Developments - Importance and How to Use This Section6.1.1 Importance of These Developments6.1.2 How to Use This Section6.2 Seegene, Microsoft Collaborate for MDx Development6.3 QuidelOrtho Expanding Savanna Test Menu6.4 Binx Health Refocuses on POC STI Testing6.5 Qiagen, Myriad Genetics Partner to Develop Cancer Dx6.6 VedaBio Detecting Nucleic Acid With CRISPR6.7 Evvy Launches Add-on STI Screen6.8 ChromaCode Shifts to Oncology with dPCR Lung Cancer Test6.9 Multiplex Meningitis/Encephalitis Panel Market Expanding6.10 Sensible Dx to Launch 10-Minute POC PCR System6.11 ReadyGo Dx Plans to Make MDx Testing Easy6.12 Transformative Biotech Acquires Summit Biolabs' PCR Tech6.13 Visby Medical POC STI Multiplex Test Cleared6.14 Sherlock Biosciences Buys Sense Biodetection6.15 Agilent, Qiagen Nab FDA Approvals for Lung Cancer Treatment CDx6.16 HealthTrackRx Investing in Rapid Turnaround Times6.17 LEX Dx Developing Ultra-Fast Low-Cost PCR6.18 Next-Gen Dx Technologies Face Uncertain Future6.19 Rover Dx Developing All-Optical Rapid POC qPCR Platform6.20 ProtonDx Plans Rapid Molecular Dx Instrument6.21 Innova Medical Group Licenses MDx Tech6.22 MicroGEM to Grow Market for 30-Minute RT-PCR System6.23 Precipio Receives CE-IVD Mark for Cancer Panels6.24 Siemens Healthineers to Develop Next-Gen MDx Platform6.25 New York State Approves Enzo Biochem HPV Molecular Test6.26 Grip Molecular Developing Biosensor Panel to Detect Respiratory Infections6.27 Co-Diagnostics Seeks EUA for At-Home PCR Diagnostic System6.28 Chelex-Based Protocol to Reduce Cost, Time for PCR Testing6.29 Finnish Firms to Form Point-of-Care Testing Firm6.30 Visby Medical Scales Up Handheld PCR Test for STIs6.31 DnaNudge Raises $60M6.32 Roche Reports Diagnostics Revenue Up 51 Percent6.33 BforCure Preparing Multiple ID Panels for PoC qPCR Platform6.34 Enzo Biochem, CLX Health Partner for C19 Testing for Travel6.35 Bio Molecular Systems Gets Approval for Portable PCR Cycler6.36 Roche Acquires GenMark6.37 Handheld qPCR Devices Close to Commercialization6.38 Nuclein Closes $14M in Funding6.39 WuXi Diagnostics Closes $150M Series B Financing Round6.40 Visby Medical to develop rapid Flu-COVID PCR test6.41 Thermo Fisher to Acquire Mesa Biotech 7 Profiles of Key PCR Companies7.1 Abbott Laboratories7.2 Accelerate Diagnostics7.3 Ador Diagnostics7.4 ADT Biotech7.5 Agilent7.6 Akonni Biosystems7.7 Altona Diagnostics7.8 Alveo Technologies7.9 Amoy Diagnostics Co., Ltd.7.10 Anatolia Geneworks7.11 Applied BioCode7.12 Applied DNA Sciences7.13 Aurora Biomed7.14 Aus Diagnostics7.15 AVIVA Systems Biology7.16 Beckman Coulter Diagnostics (Danaher)7.17 Becton, Dickinson and Company7.18 Binx Health7.19 Biocartis7.20 bioMerieux Diagnostics7.21 Bioneer Corporation7.22 Bio-Rad Laboratories, Inc7.23 Bosch Healthcare Solutions GmbH7.24 Bruker7.25 Caris Molecular Diagnostics7.26 Cepheid (Danaher)7.27 Credo Diagnostics Biomedical7.28 CTK Biotech7.29 Cue Health7.30 Curetis (OpGen)7.31 Diagenode Diagnostics (Hologic)7.32 Diasorin S.p.A.7.33 Eiken Chemical7.34 Enzo Biochem7.35 Eurofins Scientific7.36 Fluxergy7.37 Fujirebio7.38 Genetic Signatures7.39 GenMark Dx (Roche)7.40 Greiner Bio-One7.41 Hologic7.42 Immunexpress7.43 Inflammatix7.44 Invetech7.45 J&J Innovative Medicine7.46 Karius7.47 LumiraDx7.48 Maxim Biomedical7.49 Meridian Bioscience7.50 Millipore Sigma7.51 Molbio Diagnostics7.52 Nanomix7.53 NGeneBio7.54 Novacyt7.55 Nuclein7.56 Operon7.57 Panagene7.58 Precipio7.59 Primerdesign (Novacyt)7.60 Promega7.61 Prominex7.62 Qiagen7.63 QuantuMDx7.64 QuidelOrtho7.65 Randox Toxicology7.66 R-Biopharm AG7.67 Revvity7.68 Roche Diagnostics7.69 Scope Fluidics7.70 SD Biosensor7.71 Seegene7.72 Siemens Healthineers7.73 SkylineDx7.74 Sona Nanotech7.75 SpeeDx7.76 Standard BioTools7.77 Stilla Technologies7.78 Streamline Scientific7.79 T2 Biosystems7.80 Thermo Fisher Scientific7.81 Uniogen7.82 Vela Diagnostics7.83 Veramarx7.84 Veredus Laboratories7.85 Vircell7.86 Visby Medical7.87 XCR Diagnostics7.88 YD Diagnostics7.89 Zhejiang Orient Gene Biotech 8 The Global PCR Markets8.1 PCR - Global Market Overview by Country8.2 Global Market by Application - Overview8.3 Global Market by Technology - Overview8.4 Global Market by Product - Overview8.5 Global Market by Place - Overview 9 Global PCR Markets - By Application9.1 PCR Clinical Multiplex9.2 PCR Clinical Singleplex9.3 PCR Research 10 Global PCR Markets - By Technology10.1 qPCR10.2 dPCR 11 Global PCR Markets - By Product11.1 PCR Instruments11.2 PCR Nucleic Acid Extraction11.3 PCR Consumables11.4 PCR Services 12 Global PCR Markets - By Place12.1 PCR Clinical Laboratory12.2 PCR Point of Care12.3 PCR Commercial12.4 PCR Pharmaceutical 13 Appendices13.1 Growth of Approved IVD Test Menu13.2 Growth of Approved Average IVD Test Fee13.3 The Most Used IVD Assays13.4 The Highest Grossing Assays13.5 Laboratory Fees Schedule For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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