Cassava Sciences Inc. (NASDAQ:SAVA) experienced a significant drop in stock value on Monday following the release of topline data from its Phase 3 ReThink-ALZ study of simufilam, an investigational drug for mild-to-moderate Alzheimer’s disease.
Study failed to meet its pre-specified endpoints
The study failed to meet its pre-specified co-primary, secondary, and exploratory biomarker endpoints.
In a letter to shareholders and employees in July, CEO Rick Barry had expressed optimism about simufilam, emphasizing the company’s advanced progress in testing the drug and its deep financial and emotional investment.
The co-primary endpoints of the trial focused on changes in cognition and function from baseline to the conclusion of the double-blind treatment period at week 52. These were measured using the ADAS-COG12 and ADCS-ADL scales, comparing the performance of simufilam against a placebo.
Despite the disappointing outcomes, simufilam maintained an overall favorable safety profile.
Cassava Sciences announces discontinuation of second Phase 3 trial
Commenting on the results, Barry stated, “The results are disappointing… We took careful measures to enroll patients with mild-to-moderate AD. Despite that, the loss of cognition in the placebo group was less pronounced than was previously reported in other placebo-controlled studies in AD…”
As a result of the failed trial, Cassava Sciences announced the discontinuation of its second Phase 3 trial, ReFocus-ALZ, as well as the Open Label Extension study. However, the complete 52-week dataset from the ReThink-ALZ study, along with a significant portion of 76-week data, will be made available for review.
The company stated that it will continue analyzing the data and determine its next steps, with plans to present detailed findings at a future medical conference.
Cassava Sciences controversies
This news follows previous controversies surrounding Cassava Sciences. In September, the company agreed to pay over $40 million to resolve charges brought by the U.S. Securities and Exchange Commission (SEC) over misleading statements related to a Phase 2 trial of simufilam.
The SEC also charged Hoau-Yan Wang, a consultant and co-developer of the drug, with manipulating trial results. According to the SEC’s investigation, Cassava had disclosed manipulated data in September 2020, which falsely indicated significant improvements in Alzheimer’s biomarkers, such as total tau and phosphorylated tau.
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