Patient enrollment update for phase III studies of simufilam for the treatment of Alzheimer’s disease

Simufilam, an oral drug, is Cassava Sciences’ proprietary lead drug candidate.A total of 953 Alzheimer’s patients are now enrolled across Cassava Sciences’ Phase III studies. For each Phase III study, patient enrollment has passed the halfway mark of the target patient enrollment. The enrollment target for both (not each) Phase III clinical studies is approximately 1,750 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria. There are no interim analyses in Cassava Sciences’ Phase III studies.

James W. Kupiec, MD, Chief Medical Officer of Cassava Sciences, commented, “We are pleased with the recent pickup in the pace of patient enrollment with our Phase III studies, which are designed to evaluate the safety and efficacy of simufilam in patients with Alzheimer’s disease.”

“We anticipate the completion of patient enrollment for both of our Phase III studies by year-end 2023,” said Remi Barbier, Present & CEO. “Based on recent enrollment trends, we think this is a realistic expectation for completing patient enrollment.”

Phase III Program with Simufilam: Cassava Sciences is currently evaluating simufilam tablets for Alzheimer’s disease dementia in two Phase III clinical studies. These are randomized, double-blind, placebo-controlled trials. Both Phase III studies have received a Special Protocol Assessment (SPA) from the FDA. Both Phase III studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). The Phase III studies are actively recruiting Alzheimer’s patients in over 100 clinical sites in the United States, Canada, Puerto Rico, South Korea and Australia.