Cassava Sciences Stock Rises On Interim Safety Review Of Simufilam Phase 3 Trials

Cassava Sciences, Inc. SAVA on Tuesday announced the completion of an interim safety review of its Alzheimer's drug candidate, simufilam. Here’s what you need to know.

Recap

Cassava Sciences reported the completion of its third interim safety review for simufilam, a novel oral drug aimed at treating Alzheimer's disease. The Data and Safety Monitoring Board (DSMB), made up of independent clinical research experts, reviewed patient safety data from Cassava’s Phase 3 trials but did not assess the drug's efficacy. The DSMB recommended both trials continue without any changes.

Phase 3 trials of simufilam are fully enrolled, with over 1,900 patients with mild-to-moderate Alzheimer's disease. The trials are being conducted in collaboration with Premier Research International, a global contract research organization.

• First Phase 3 Trial (NCT04994483): This trial involves 804 Alzheimer's patients over a 52-week treatment period. The top-line results are expected by the end of 2024.
• Second Phase 3 Trial (NCT05026177): This trial has 1,125 patients and is running for a 76-week period, with results expected around mid-2025.

The company also noted earlier MRI safety data from 2023 that indicated simufilam was not associated with amyloid-related imaging abnormalities (ARIA), a common issue in Alzheimer's treatments.

SAVA Price Action: Cassava Sciences shares were up by 3.28% at $27.89 according to Benzinga Pro.

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