Cassava Posts Encouraging Data From Interim Analysis Of Open-label Simufilam Study In Alzheimer's

(RTTNews) - Cassava Sciences, Inc. (SAVA) reported top-line clinical data from a pre-planned interim analysis of an on-going open-label study with its drug candidate simufilam in patients with mild-to-moderate Alzheimer's disease. In the study, ADAS-Cog11 scores improved an average of 3.2 points from baseline in the first 50 study subjects who completed 12 months of open-label treatment with simufilam. There were no drug-related serious adverse events through the interim analysis, the company said.

Remi Barbier, President & CEO, said: "We look forward to the initiation of a randomized, double-blind, placebo-controlled pivotal phase 3 clinical program with simufilam in people with Alzheimer's disease."

The company noted that treatment effects observed in an open-label study are not proof of drug safety or efficacy, nor can open-label data predict clinical success in a phase 3 program. It is advancing simufilam into a phase 3 clinical program. Study initiation is on-track for the fourth quarter 2021, the company said.

Shares of Cassava Sciences were up 13% in pre-market trade on Wednesday.