AUSTIN, Texas - Cassava Sciences, Inc. (NASDAQ:SAVA), a biotechnology company, announced top-line results from a two-year clinical safety study of simufilam, its investigational drug for Alzheimer’s disease. The study involved over 200 patients with mild to moderate Alzheimer's and included a randomized, placebo-controlled withdrawal phase.
Patients with mild Alzheimer's who received continuous simufilam treatment for two years exhibited no decline in ADAS-Cog scores, which measure cognitive function. In contrast, those who received the drug non-continuously for the same period showed a slight decline. The most significant difference between continuous and non-continuous treatment groups was observed after a six-month placebo-controlled withdrawal phase.
In patients with moderate Alzheimer's, continuous treatment over two years resulted in an 11.05-point decline on the ADAS-Cog scale. The study also reported that simufilam was safe and well-tolerated, with no drug-related serious adverse events. The most common adverse events were unrelated to the medication, such as Covid-19 and urinary tract infections.
The study's cognitive endpoints were analyzed by Pentara Corporation, an independent consulting firm specializing in statistical analysis of clinical trial results. While these findings suggest potential benefits of continuous treatment with simufilam, the open-label design and limited size of the study may introduce bias or generate results that do not fully distinguish between drug effects and random variation.
Cassava Sciences emphasizes that the data from this open-label safety study do not constitute regulatory evidence of safety or efficacy for simufilam. Rigorous evidence typically comes from large, randomized, placebo-controlled studies. The company is currently evaluating simufilam in two fully enrolled global Phase 3 clinical studies, with top-line results expected by the end of 2024 and mid-year 2025, respectively.
The information in this article is based on a press release.
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