Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced the initiation of an open-label extension study. This study is designed to provide no-cost access to simufilam, an investigational drug, to patients with Alzheimer’s disease who complete either one of Cassava Sciences’ on-going Phase 3 studies, which are double-blind, placebo-controlled trials.

“We believe this open-label study is the right thing to do,” said Remi Barbier, President & CEO. “Alzheimer’s patients who complete one of our Phase 3 studies are eligible to enroll, knowing there is no placebo and no blinding in our open-label extension study.”

Open-label Extension Study Design
This multi-center, multi-national, open-label extension study is expected to generate long-term safety and tolerability data for (oral) simufilam 100 mg twice daily over 52 weeks. Each clinical investigational site must choose whether to participate in this open-label extension study. Patient enrollment for this study is expected to begin early November 2022.

For more information about the open-label-extension study, please visit ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT05575076?term=simufilam&draw=2&rank=1

Overview of On-going Phase 3 Clinical Program
Our Phase 3 program consists of two double-blind, randomized, placebo-controlled studies of simufilam, with an enrollment target of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration. For more information about our Phase 3 studies, please visit ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT04994483?term=simufilam&draw=2&rank=3
https://www.clinicaltrials.gov/ct2/show/NCT05026177?term=simufilam&draw=2&rank=4