Cassava Sciences Topline Phase 3 Data Did Not Meet Co-Primary Endpoints

Core Insights - Simufilam did not demonstrate a significant reduction in cognitive or functional decline compared to placebo in patients with mild-to-moderate Alzheimer's disease in the ReThink-ALZ Phase 3 study [1][2] - The company plans to present the data at an upcoming medical meeting and will hold a webcast to discuss the results [1][7] - The overall safety profile of Simufilam remains favorable despite the study results [1][4] Study Details - The ReThink-ALZ trial involved 804 participants with mild or moderate Alzheimer's disease, randomized to receive either Simufilam 100 mg or a placebo for 52 weeks [8] - Co-primary endpoints included changes in cognition and function assessed by ADAS-COG12 and ADCS-ADL scales, with no statistical significance observed [3][9] - The loss of cognition in the placebo group was less pronounced than in previous studies, prompting further investigation [2] Safety and Demographics - The safety data indicated that 71.2% of Simufilam participants experienced any adverse event, compared to 67.6% in the placebo group [5][6] - The demographic data showed a mean age of 73.7 years for the Simufilam group and 74.3 years for the placebo group, with a balanced gender distribution [5][6] Future Plans - The company has decided to discontinue the ReFocus-ALZ trial and the Open Label Extension study due to the results of the ReThink-ALZ study [2] - Detailed analyses of both studies will be reported in the future [2][7] - Cassava Sciences remains focused on enhancing shareholder value and is well-capitalized with approximately $149 million in cash as of the end of Q3 2024 [7]