Investing.com -- Cassava Sciences (NASDAQ:SAVA), Inc., a biotechnology company focused on Alzheimer's disease treatments, disclosed that its Phase 3 ReThink-ALZ study for the investigational drug simufilam did not achieve the targeted outcomes.
The study aimed to improve cognition and function in patients with mild-to-moderate Alzheimer's disease but failed to meet the co-primary, secondary, and exploratory biomarker endpoints.
The co-primary endpoints were based on changes in cognition and function from the start of the study to the end of the 52-week treatment period. These were assessed using the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to a placebo. Despite the unfavorable results, simufilam maintained an overall favorable safety profile.
Rick Barry, President and CEO of Cassava, expressed his disappointment for patients, their families, and physicians who have been seeking new treatment options. He noted that the cognitive decline in the placebo group was less severe than in other Alzheimer's studies, which was unexpected.
As a result of these findings, Cassava has decided to discontinue its second Phase 3 trial, ReFocus-ALZ, as well as the Open Label Extension study. Detailed analyses of the complete 52-week dataset and a significant portion of 76-week data will be reported in the future.
Barry also extended his gratitude to the patients, families, caregivers, employees, study investigators, site coordinators, and partners who participated in the clinical program. He hopes that the data collected from the studies will contribute to future Alzheimer's research.
Following the announcement, shares of Cassava Sciences plummeted by 85% on Monday. In response to the study's outcome, Rodman & Renshaw analyst Elemer Piros downgraded Cassava Sciences from Buy to Sell, setting a new price target of $2.00, down from the previous target of $107.00.
Piros justified the new price target by equating it to Cassava's projected cash position of approximately $100 million over the next 12 months.
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