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  • DSMB recommends the phase III trials of simufilam ...

DSMB recommends the phase III trials of simufilam continue as planned, without modification

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Published:19th Sep 2023

Cassava Sciences, Inc. announced a positive interim safety review of simufilam in on-going Phase III clinical trials in patients with Alzheimer’s disease.

A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences’ Phase III studies of simufilam continue as planned, without modification.

The DSMB is composed of independent clinical research experts who periodically review interim patient safety data for Cassava Sciences’ on-going Phase III trials of simufilam in Alzheimer’s disease. This DSMB only reviews patient safety. It does not assess drug efficacy. The next routine meeting of the DSMB is scheduled for March 2024.

On-going Phase III Studies with Simufilam : Cassava Sciences is evaluating simufilam oral tablets for Alzheimer’s disease dementia in two global Phase III clinical studies. These are randomized, double-blind, placebo-controlled trials. The Phase III program aims to enroll a total of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria. Patient enrollment is expected to be completed for both Phase III studies by year end 2023. Both Phase III studies have received a Special Protocol Assessment (SPA) from the FDA.

Condition: Alzheimers
Type: drug

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