AUSTIN, Texas - Cassava Sciences, Inc. (NASDAQ:SAVA), a biotechnology firm specializing in Alzheimer’s disease research, received a nod from an independent Data and Safety Monitoring Board (DSMB) to proceed with its ongoing Phase 3 clinical trials for simufilam, an investigational treatment for Alzheimer's disease, without any modifications. This decision follows a routine interim safety review.
The DSMB, comprising independent clinical research experts, periodically assesses patient safety data from the ongoing trials. The board's primary focus is patient safety rather than drug efficacy. The latest DSMB recommendation supports the continuation of two pivotal Phase 3 trials, which are fully enrolled with over 1,900 patients with mild-to-moderate Alzheimer's disease across multiple international sites.
The first Phase 3 trial, with a 52-week treatment period, includes 804 patients and expects to announce top-line results by the end of 2024. The second trial, which lasts 76 weeks, involves 1,125 patients and anticipates results around mid-2025. Both trials are being conducted in collaboration with Premier Research International, a global contract research organization.
Simufilam, Cassava Sciences’ proprietary drug candidate, targets altered filamin A protein in the brain, aiming to restore its normal shape and function, which could potentially improve health outcomes for Alzheimer’s patients. The company holds exclusive, worldwide rights to simufilam without royalty obligations.
Previous interim safety data from MRI scans suggested that simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA). The final clinical safety data for simufilam are expected upon the conclusion of the Phase 3 program.
Cassava Sciences continues to maintain a strong commitment to addressing neurodegenerative diseases, with a focus on stabilizing critical proteins in the brain rather than removing them. The information for this article is based on a press release statement.
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