Cassava Sciences Announces Expansion of Open-Label Extension Trials

Core Viewpoint - Cassava Sciences, Inc. is extending its open-label extension trials for simufilam in Alzheimer's disease by up to 36 months, allowing patients to continue treatment while awaiting results from ongoing Phase 3 trials [2][8]. Group 1: Trial Details - The company is currently conducting two double-blind, randomized, placebo-controlled studies: RETHINK-ALZ, a 52-week trial with 804 patients, and REFOCUS-ALZ, a 76-week trial with 1,125 patients [4]. - The trials are being conducted at 172 clinical sites across the United States, Canada, Puerto Rico, Australia, and South Korea [4]. Group 2: Patient Commitment - Approximately 89% of patients in the ongoing Phase 3 program have chosen to continue with open-label treatment after completing the blinded trials [15]. - Prior to this extension, around 100 patients who completed the open-label Phase 3 extension trial had no option but to discontinue treatment, but they will now have the opportunity to re-enroll [15]. Group 3: Additional Monitoring - The company plans to incorporate cognition and plasma biomarker monitoring into the open-label extension trials to gather long-term data on the effects of simufilam treatment [9][10]. Group 4: Company Statements - Cassava's Executive Chairman, Rick Barry, emphasized the commitment to patients in expanding the open-label extension studies [3]. - Chief Medical Officer, James Kupiec, stated that the decision to expand the trials was in direct response to requests from clinical research sites [11]. Group 5: Future Expectations - The company expects to announce top-line results of the RETHINK-ALZ trial by the end of 2024 and for the REFOCUS-ALZ trial around mid-2025 [11].