Cassava Sciences (NASDAQ:SAVA) traded higher on Wednesday after announcing Phase 3 data to indicate that its Alzheimer’s candidate, simufilam, is not linked to a common group of side effects associated with FDA-approved Alzheimer’s medications.
Citing an independent analysis of magnetic resonance imaging (MRI) brain data from a Phase 3 trial for oral simufilam, the company said that its drug was not associated with the safety issue at Week 40.
The safety concerns it cited are MRI imaging changes called treatment-emergent amyloid-related imaging abnormalities (ARIA), such as edema and brain bleeds.
ARIAs are often linked to FDA-approved amyloid-targeting Alzheimer’s drugs such as Leqembi, developed by Biogen (BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY). Simufilam, Cassava’s (SAVA) lead asset targets filamin A, a protein linked to Alzheimer’s pathogenesis.
The company expects to report final MRI data after the 76-week trial for patients with mild-to-moderate Alzheimer’s concludes.