Completion of patient dosing in a randomized controlled trial of simufilam in Alzheimer’s disease.-Cassava Sciences, Inc.,

Simufilam is Cassava Sciences’ investigational oral drug treatment for Alzheimer’s disease dementia.

“We all know that Phase III studies, if successful, provide evidence of efficacy,” said Remi Barbier, President & CEO. “Our Cognition Maintenance Study addresses a flip side of the drug efficacy question: What happens when Alzheimer’s patients who were taking simufilam for a year stop taking the drug for six months? Differences that emerge between the group of patients that continued to take simufilam versus the group of patients randomized to placebo may suggest evidence of simufilam’s efficacy.”

The CMS is a randomized, double-blind, placebo-controlled, 6-month trial designed to evaluate the safety and efficacy of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. The CMS follows a randomized withdrawal study design. To enroll in the CMS, patients must have previously completed 12 months or more of open-label treatment with simufilam. Enrollment in the CMS was open to all patients who responded to open-label treatment, as well as to all patients who had no apparent response to open-label treatment.

CMS study participants were randomized (1:1) to simufilam or placebo. The primary outcome measures are safety and change in cognition scores (ADAS-Cog) over 6 months in over 125 patients who completed dosing. The CMS dataset remains locked and blinded. After unlocking, the dataset will be analyzed by outside biostatisticians. Subgroup analyses may include patients by stage of disease, prior response to open-label treatment, baseline scores or other crucial shared characteristics. Cassava Sciences expects to announce CMS top-line data in Q3 2023.