Cassava Sciences to announce top-line results of ReTHINK trial before year-end

In a regulatory 8-K filing, the company publishes the letter from its CEO Rick Barry, stating: “A lot has happened in the few months since I last wrote to you. It’s time that I update you on what has taken place here at Cassava and the substantial progress that we have made. I am happy to inform you that our ReTHINK Phase 3 clinical trial recently completed its last patient, last visit. All patients have completed dosing, and all that remains is to collect and analyze the data. For a company our size, this is a remarkable achievement. This study enrolled 804 patients at 77 sites in the US, Puerto Rico, Canada, and Australia. Patients were randomized 1:1 between placebo and simufilam 100 mg, twice daily. Approximately 70% of the patients entered the study with mild Alzheimer’s disease, while 30% entered with moderate Alzheimer’s. We expect to announce top-line results of the ReTHINK trial before year end. We submitted our proposed Statistical Analysis Plan to FDA in July and are now responding to comments that we have received from the agency. We expect to finalize the Statistical Analysis Plan in the near term.”