Cassava Sciences says MRI data suggests simufilam not associated with ARIA

Cassava Sciences announced a potentially significant safety finding based on interim magnetic resonance imaging brain data from Alzheimer’s patients who are enrolled in a Phase 3 clinical trial of simufilam. The MRI data suggest simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities, or ARIA. MRIs were all analyzed for ARIA by board-certified neuroradiologists. ARIA is a medical term used to describe a spectrum of brain MRI imaging abnormalities, such as edema and brain bleeds. ARIA is also a known risk factor for Alzheimer’s patients taking the class of drugs known as monoclonal antibodies directed against beta amyloid. In contrast to such class of drugs, simufilam is Cassava Sciences’ small-molecule drug candidate. Oral simufilam is currently in Phase 3 clinical testing in patients with Alzheimer’s disease dementia. The new safety finding is based on an independent, interim neuroradiological evaluation of brain MRIs taken at week 40 in a blinded sub-study of 180 Alzheimer’s patients enrolled in Cassava Sciences’ on-going 76-week Phase 3 clinical trial of simufilam in mild-to-moderate Alzheimer’s. Final MRI data is expected at the conclusion of this Phase 3 study. All Phase 3 clinical data remains blinded.