Cassava Sciences Starts Late-Stage Simufilam Study In Alzheimer's Patients

Cassava Sciences Inc SAVA initiated an initial Phase 3 efficacy study of simufilam, an investigational drug for patients with Alzheimer's disease.
A second Phase 3 efficacy study of simufilam in Alzheimer's disease is expected to begin by year-end.
Phase 3 studies of simufilam in Alzheimer's disease are conducted under Special Protocol Assessments from the FDA.
Related: Cassava Sciences Receives FDA's Special Protocol Assessment For Alzheimer's Trials.
The first Phase 3 750-subject study, called RETHINK-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing cognitive and functional decline over 52 weeks.
Secondary objectives include the assessment of simufilam's effect on neuropsychiatric symptoms and caregiver burden.
The second Phase 3 study in 1,000 patients, called REFOCUS-ALZ, will evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 78 weeks.
Related: Cassava Sciences' Simufilam Data Shows Improved Cognition In Alzheimer's Disease.
Price Action: SAVA stock is down 5.91% at $53.79 during the market session on the last check Wednesday.