Cassava Sciences Alzheimer’s Drug Development After Phase 3 Setbacks
$SAVA
Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company, has announced the discontinuation of its Alzheimer’s disease program following disappointing results from its Phase 3 REFOCUS-ALZ study. The Austin, Texas-based company reported that the investigational drug simufilam did not achieve significant reduction in cognitive or functional decline compared to placebo in patients with mild-to-moderate Alzheimer’s disease. The REFOCUS-ALZ study, which enrolled 1,125 patients, was terminated on November 25, 2024, after failing to meet its co-primary endpoints.
These endpoints included changes in cognition and function from baseline to the end of the treatment period at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales. Despite the setback, simufilam maintained a generally favorable safety profile throughout the trial. Rick Barry, President and CEO of Cassava, expressed disappointment over the trial outcomes but appreciated the integrity and dedication of the clinical teams involved.
The company has initiated preclinical studies to explore simufilam’s potential as a treatment for tuberous sclerosis complex (TSC)-related epilepsy. Eric Schoen, Chief Financial Officer of Cassava, reassured that the company remains well-capitalized, with approximately $128.6 million in cash and cash equivalents as of December 31, 2024.
This financial stability supports Cassava’s ongoing research and development efforts in other areas of neuroscience. The REFOCUS-ALZ trial was a multi-center, double-blinded, placebo-controlled study conducted across over 75 clinical sites in the US, Canada, Puerto Rico, and South Korea. It was designed to evaluate the safety and efficacy of two doses of simufilam compared to a placebo.
This development marks a significant pivot for Cassava Sciences as it navigates the challenges of drug development. The discontinuation of the Alzheimer’s program underscores the complexities and uncertainties inherent in developing treatments for such a debilitating disease. Cassava’s decision to redirect its efforts towards other neurological disorders highlights a strategic adaptation to the dynamic nature of biotechnological research and development.
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