Cassava Says Simufilam Failed in Alzheimer’s Study

Cassava Sciences says topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease show that the study did not meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints. The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at Week 76. The study, which enrolled 1,125 patients, was discontinued in November following a report that a prior 52-week Phase 3 study, RETHINK-ALZ, did not meet its co-primary endpoints, it notes.

“We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer’s disease,” Cassava says “These results were unambiguous.” The company now says it will discontinue all efforts to develop simufilam for Alzheimer’s disease and expects to phase out the program by the end of the second quarter.