Following a recent strategic announcement, Cassava Sciences, Inc. (NASDAQ: SAVA) is experiencing a significant uptick in its stock performance. As of the latest market update, SAVA shares are trading at $20.72, marking an increase of 17.93%.
Extension of Open-Label Trials
Cassava Sciences (SAVA) has disclosed that it intends extending its open-label extension studies for its ongoing Phase 2 and Phase 3 clinical programs by a maximum of 36 months each. Patients who previously took part in simufilam randomized studies for Alzheimer’s disease will be allowed to continue their treatment in an open-label situation if they so want thanks to this update to the study procedures.
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The extension is designed to bridge the interval between the conclusion of treatment in clinical trials and the Company’s submission of trial results to regulatory bodies. The open-label extension period may last up to 36 months or until the FDA has reviewed a new drug application for simufilam.
Enhanced Monitoring and Patient Re-enrollment
In addition, Cassava Sciences intends to incorporate cognition and plasma biomarker monitoring into the open-label extension trial for patients who have completed the Phase 3 studies. This will facilitate the collection of additional long-term data regarding the efficacy of simufilam treatment.
Currently, about 89% of participants in the ongoing Phase 3 program have opted to continue with simufilam treatment in an open-label setting after the conclusion of the blinded trials. Prior to this update, around 100 patients who completed the open-label Phase 3 extension trial faced discontinuation of treatment. These individuals will now have the option to re-enroll in the open-label extension trial, responding to requests from clinical research sites.
Current and Upcoming Trials
Two double-blind, randomised, placebo-controlled trials of simufilam are being carried out by Cassava Sciences in individuals with mild-to-moderate dementia caused by Alzheimer’s disease. About 172 clinical locations in the US, PR, Canada, South Korea, Australia, and South Korea are participating in these studies.
Top-line findings from the RETHINK-ALZ study are scheduled to be released by the company by the end of 2024, while data from the REFOCUS-ALZ trial should be available by the middle of 2025.
