Cassava Sciences, Inc. (SAVA) has reported positive news for its Alzheimer’s drug candidate, simufilam. The company announced the successful completion of an interim safety review for the drug, paving the way for its ongoing Phase 3 trials to continue without any alterations.
The independent Data and Safety Monitoring Board (DSMB), comprised of clinical research experts, meticulously reviewed patient safety data from Cassava’s Phase 3 trials. Importantly, the DSMB’s review focused solely on safety and did not assess the drug’s efficacy. Following their thorough evaluation, the DSMB recommended that both Phase 3 trials proceed without any changes.
These Phase 3 trials are currently fully enrolled, with over 1,900 patients with mild-to-moderate Alzheimer’s disease participating. The trials are being conducted in partnership with Premier Research International, a global contract research organization.
Here’s a breakdown of the two Phase 3 trials:
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First Phase 3 Trial (NCT04994483):
This trial involves 804 patients with Alzheimer’s disease and will run for a 52-week treatment period. The top-line results from this trial are anticipated by the end of 2024.*
Second Phase 3 Trial (NCT05026177):
This trial is designed for 1,125 patients and has a longer duration of 76 weeks. Results from this trial are expected around mid-2025.In addition to the recent safety review, Cassava Sciences had previously released MRI safety data from 2023, indicating that simufilam was not associated with amyloid-related imaging abnormalities (ARIA). ARIA is a known potential issue with some Alzheimer’s treatments.
The news of the successful safety review has been well-received by investors. Cassava Sciences shares saw an increase of 3.28% to $27.89 according to Benzinga Pro. This positive development could be a significant step forward in the quest to develop effective treatments for Alzheimer’s disease.
