Cassava Sciences, Inc. announced a potentially significant safety finding based on interim magnetic resonance imaging (MRI) 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. In contrast to such class of drugs, simufilam is Cassava Sciences' small-molecule (oral) 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 (NCT#05026177). Final MRI data is expected at the conclusion of this Phase 3 study.

All Phase 3 clinical data remains blinded. The MRI data and two other datasets will be presented at the 16th Clinical Trials on Alzheimer's Disease (CTAD) conference taking place in Boston, MA, October 24-27th, 2023: LP036: "Interim MRI Safety Analysis from a 76-week Phase 3 Clinical Trial of Simufilam in Alzheimer's disease. The product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established in humans.