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The second Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 78 weeks over 78 weeks in approximately 1,000 patients.
Cassava Sciences' is conducting the Phase 3 program in Alzheimer's under Special Protocol Assessments (SPA) from the FDA.
The first Phase 3 RETHINK-ALZ study 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.
This study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer's disease.
The Company commenced patient screening for RETHINK-ALZ in October 2021, followed by patient dosing in November 2021.
Recently, SEC launched a probe into claims that Cassava Sciences' manipulated data key to its case for simufilam.
Price Action: SAVA shares are up 0.57% at $47.34 during the market session on the last check Thursday.
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