Cassava Sciences announces expansion of open-label extension trials
Cassava Sciences, Inc. announced that the Company will extend by up to an additional 36 months each of the open-label extension trials in its ongoing Phase II and Phase III clinical programs. These amendments to the protocols will allow patients who have previously participated in a randomized trial of simufilam in Alzheimer’s disease, if they desire, to continue open-label treatment with simufilam
This expansion of the open-label extension trials offers a bridge for any gap between patients ending treatment in a clinical trial and the Company reporting to regulatory authorities the results of the ongoing, randomized, placebo-controlled Phase III trials. The open-label extension can continue for up to 36 months or until a new drug application for simufilam has been reviewed by FDA.
Cassava also plans to add cognition and plasma biomarker monitoring to its open-label extension trial for patients who have completed the Phase III trials in order to gather additional long-term data on the potential impact of simufilam treatment.
“For a company of our size, it is not a trivial commitment to expand our open-label extension studies in this manner. But we believe that this is the best answer for our patients and, ultimately, that is who we serve,” said Cassava Executive Chairman Rick Barry.
Approximately 89% of patients in Cassava’s ongoing Phase III program have elected to continue with open-label treatment with simufilam after completion of the blinded trials. Prior to this announced change, approximately 100 patients completed the open-label Phase III extension trial and had no option but to discontinue treatment. These patients will now be given the opportunity to re-enroll in an open-label extension trial, if they choose to do so.
Ongoing Phase III Studies of Simufilam in Alzheimer’s Disease: Cassava is currently running two double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. RETHINK-ALZ is a 52-week trial in which 804 patients were randomized 1:1 between simufilam 100 mg and placebo. REFOCUS-ALZ is a 76-week trial in which 1,125 patients were randomized 1:1:1 between simufilam 100 mg, simufilam 50 mg, and placebo. The trials are being conducted at 172 clinical sites in the United States, Canada, Puerto Rico, Australia, and South Korea.
The Company expects to announce top-line results of RETHINK-ALZ by the end of 2024. Top-line results for REFOCUS-ALZ are anticipated approximately mid-2025.
Open-label Extension Study Design: These studies are designed to provide no-cost access to oral simufilam to Alzheimer’s patients who have successfully completed a Phase II or Phase III study of simufilam and who meet other entry criteria. Each clinical investigational site must choose whether to participate in the open-label extension studies.
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