Cassava Sciences announces positive end-of-phase II meeting with FDA and outlines pivotal phase III program for simufilam in Alzheimer’s disease.

Cassava Sciences, Inc. announced the successful completion of an End-of-Phase II (EOP2) meeting with the FDA for simufilam, its lead drug candidate for the treatment of Alzheimer’s disease. Official EOP2 meeting minutes indicate FDA and Cassava Sciences agree on key elements of a pivotal Phase III clinical program in support of a New Drug Application (NDA) filing for simufilam in Alzheimer’s disease. Agreements reached during the EOP2 meeting show a clear path forward for advancing simufilam into Phase III studies in the second half of 2021. Simufilam is a novel drug, discovered at Cassava Sciences, that targets both neuroinflammation and neurodegeneration. The EOP2 meeting discussion was supported by years of scientific and clinical data, including positive results from a previously completed Phase II clinical program with simufilam in Alzheimer’s disease. In a double-blind, randomized, placebo-controlled Phase IIb study, simufilam demonstrated robust effects on primary and secondary outcome measures, with no safety issues. Recently, the Company announced that simufilam improved cognition in subjects with Alzheimer’s disease in a 6-month interim analysis of an open-label study, with no safety issues.