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 ( SAVA ) 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 ( SAVA ) shares were up by 3.28% at $27.89 according to Benzinga Pro.

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