Cassava Sciences Alzheimer's Drug Fails To Hit Primary Goal In Pivotal Study, Pharma Halts Late-Stage Studies

Core Viewpoint - Cassava Sciences Inc. experienced a significant decline in stock price following the release of disappointing topline data from the Phase 3 ReThink-ALZ study of simufilam for mild-to-moderate Alzheimer's disease [1][8]. Study Results - The Phase 3 ReThink-ALZ trial did not meet the pre-specified co-primary, secondary, and exploratory biomarker endpoints, which included changes in cognition and function assessed by ADAS-COG12 and ADCS-ADL scales [2]. - Despite the disappointing results, simufilam maintained an overall favorable safety profile [3]. Impact on Future Trials - The failed results from the ReThink-ALZ trial have led the company to discontinue its second Phase 3 trial, ReFocus-ALZ, as well as the Open Label Extension study [4]. Data Review and Future Plans - The complete 52-week dataset, along with a significant portion of the 76-week data, will be reviewed, and the company plans to share detailed results at a future medical meeting [5]. Regulatory Issues - Cassava Sciences has faced scrutiny for allegedly fabricating data from simufilam drug trials, resulting in a settlement of over $40 million with the SEC regarding misleading statements related to a Phase 2 trial [6]. - The SEC's investigation revealed that manipulated data was disclosed in September 2020, falsely indicating significant improvements in Alzheimer's biomarkers [7].