Shares of Cassava Sciences (SAVA) - Get Report jumped on Monday after the drugmaker said that in the second half it planned a Phase 3 clinical trial for its Alzheimer's treatment candidate, simufilam.
“We started 2021 with tremendous momentum, led by results of a six-month interim analysis from an open-label study of simufilam, our drug candidate for Alzheimer’s disease,” Chief Executive Remi Barbier said in a statement. “I believe the rest of the year may be equally exciting.”
Cassava at last check was up 12% to $50.34.
Cassava plans a six-month double-blind, randomized, placebo-controlled study in patients with Alzheimer's who complete at least one year of open-label treatment with simufilam. That study is scheduled for the second half of 2021.
The company also plans to expand the size of the ongoing open-label study of simufilam by as many as 50 additional patients with mild-to-moderate Alzheimer's disease. The company to enroll a total 150 patients for the study.
Earlier this month, the Austin company reported results from a study of simufilam, which was associated with improved patient cognition and behavior scores after six months of treatment.
“We would have been satisfied to show simufilam stabilizes cognition in patients over six months. An improvement in cognition and behavior tells us this drug candidate has potential to provide lasting treatment effects for people living with Alzheimer’s disease," Barbier said.
The clinical study was funded by the National Institutes of Health.
The study is part of a continuing one-year study to evaluate the long-term safety and tolerability of a twice-daily 100mg dose of simufilam in 100 patients with mild-to-moderate Alzheimer's disease. The company started the trial in March 2020.