- Cassava Sciences Inc (NASDAQ: SAVA) completes an End-of-Phase 2 (EOP2) meeting with the FDA for its lead candidate, simufilam, in Alzheimer’s disease. The FDA and Cassava Sciences agree on key elements of a pivotal Phase 3 program for simufilam, which would include two double-blind, randomized, placebo-controlled studies.
- First Phase 3 study will enroll approximately 1,000 subjects with mild-to-moderate Alzheimer’s disease that will be treated for 18 months. Co-primary efficacy endpoints are a cognitive scale and a functional scale. Secondary efficacy endpoint combines cognitive and functional scores. The study will start in Q3 2021.
- Second Phase 3 study in 600 mild-to-moderate Alzheimer’s disease patients, who will be treated for 9 to 12 months. Primary and secondary efficacy endpoints remain the same as the first Phase 3 trial. It will start in Q4 of 2021.
- As previously announced, the company plans to initiate a six-month Cognition Maintenance Study in Q2 2021 in patients who have completed at least one year of open-label treatment with simufilam.
- The study will compare simufilam’s effects on cognition and dementia-related in subjects who continue with drug treatment versus those who discontinue drug treatment.
- Also, earlier this month, SAVA raised $200 million to fund the development of simufilam.
- Price Action: SAVA gained 6.69% at $59.49 on the last check Monday.
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