Cassava Sciences Topline Phase 3 Data Did Not Meet Co-Primary Endpoints
SAVA 11.25.2024
Drug:100 mg Simufilam
Diseases:Alzheimer's disease
Date of Upcoming Event:2024-11-25
Name of Upcoming Event:Medical Meeting
About Gravity Analytica
Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Phase 3 study
Simufilam continued to demonstrate an overall favorable safety profile
Cassava intends to present the data at an upcoming medical meeting
The Company will hold a webcast today,
“The results are disappointing for patients and their families who are living with this disease and physicians who have been looking for novel treatment options. We took careful measures to enroll patients with mild-to-moderate AD. Despite that, the loss of cognition in the placebo group was less pronounced than was previously reported in other placebo-controlled studies in AD. We are working to understand this better,” said
The table below provides a high-level summary of the co-primary endpoints data. Topline analysis of the mild and moderate sub-groups, likewise, did not demonstrate statistical significance at week 52.
| Co-Primary EndpointData* | Simufilam 100 mg BIDN= 403 | Placebo BIDN=401 | Delta | P-value |
| Co-Primary EndpointsLS means change from baseline to the end of the double-blind treatment period | ||||
| ADAS-COG12 (SE) | 2.8 ( 0.36) | 3.2 ( 0.36) | -0.39 ( 0.50) | P=0.43 |
| ADCS-ADL (SE) | -3.3 ( 0.44) | -3.8 ( 0.44) | 0.51 ( 0.61) | P=0.40 |
| *Based on the intent-to-treat populationBID = twice dailyADAS-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) | ||||
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 | Placebo BID |
| Baseline* | ||
| Age, mean (SD), in years | 73.7 7.9 | 74.3 7.6 |
| Sex, n (%) female | 225 (55.8%) | 222 (55.4%) |
| MMSE Score (No.%,) | ||
| 21-27 | 244 (60.5%) | 250 (62.3%) |
| 16-20 | 155 (38.5%) | 146 (36.4%) |
| Race/Ethnicity | ||
| White | 366 (90.8%) | 376 (93.8%) |
| Black | 20 (5.0%) | 18 (4.5%) |
| Asian | 8 (2.0%) | 2 (0.5%) |
| Other | 9 (2.2%) | 5 (1.0%) |
| Safety** | ||
| Any Adverse Event (AE) | 284 (71.2%) | 269 (67.6%) |
| Serious AEs | 52 (13.0%) | 36 (9.0%) |
| Death | 1 (0.3%) | 3 (0.8%) |
| AEs leading to discontinuation from the study | 26 (6.5%) | 17 (4.3%) |
| Most Frequent AEs | ||
| 1: COVID-19 | 32 (8.0%) | 36 (9.0%) |
| 2: Urinary Tract Infection | 31 (7.8%) | 29 (7.3%) |
| 3: Fall | 30 (7.5%) | 30 (7.5%) |
| 4: Dizziness | 21 (5.3%) | 1 (0.3%) |
| 5: Headache | 18 (4.5%) | 11 (2.8%) |
| *Based on the intent-to-treat population**Based on the safety populationBID = twice dailyAD = Alzheimer’s diseaseMMSE = Mini-Mental State Examination | ||
Cassava will continue to review all of the data and evaluate next steps. We plan to share the detailed results at a future medical meeting.
| Webcast Info | |
| Date: | |
| Time: | |
| Webcast: | https://lifescievents.com/event/cassava/ |
A webcast of the live call will be available in the investor relations section of the Cassava website. Access to the webcast replay will be available on the Company’s website approximately two hours after completion of the call for approximately 90 days.
About Re-THINK-ALZ
ReThink-ALZ(NCT04994483) is a Phase 3 trial designed to evaluate the safety and efficacy of simufilam compared to a placebo in a multi-center, double-blinded, placebo-controlled, randomized parallel group study involving over 75 clinical trial sites in the
The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo. Secondary endpoints also included several well validated measures of neuropsychiatric symptoms and caregiver burden. Safety was evaluated through multiple measures, including adverse event monitoring. The study also included a pharmacokinetic and plasma biomarker sub-study comprised of approximately 100 subjects, evaluated at three timepoints. ReThink-ALZ was conducted under a Special Protocol Assessment (SPA) with the
About Simufilam
Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein.
About
Simufilam, an investigational oral, small molecule drug candidate that targets the filamin A protein, is under evaluation for the potential treatment of Alzheimer's disease.
For more information, please visit:https://www.CassavaSciences.com
For More Information Contact:
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Mediamedia@cassavasciences.com
Company
Cautionary Note Regarding Forward-Looking Statements:This news release contains forward-looking statements that include but are not limited to statements regarding: the completion and future results of our Phase 3 clinical studiesof simufilam in patients with Alzheimer's disease; the planned discontinuation of the ReFocus-ALZ and open-label extension studies; our intent to share detailed study results at a future medical meeting; the timing of anticipated milestones; and the potential for simufilam to be approved as a treatment for Alzheimer’s disease. 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 conduct or complete clinical studies on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits of simufilam; our current expectations regarding timing of clinical data for our Phase 3 studies; and other risks inherent in drug discovery and development or specific to
All of our pharmaceutical assets under development are investigational product candidates. These 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.
Source: Cassava Sciences, Inc.