Cassava Sciences ( NASDAQ: SAVA ) dropped ~17% on Tuesday morning after reporting top-line Phase 2 results for its oral Alzheimer’s candidate simufilam from a study involving patients with mild-to-moderate disease.
The open label trial involved more than 200 patients who received simufilam tablets at 100mg twice daily for one year or more.
According to the company, they indicated a minimal change in ADAS-Cog mean scores, a popular cognitive scale used in Alzheimer’s clinical research and the trial’s primary efficacy endpoint.
47% of patients who improved on ADAS-Cog over one year showed a 4.7-point mean improvement, while 23% witnessed less than a 5-point decline on ADAS-Cog with a mean change of 2.5 points.
Cassava ( SAVA ) said the treatment’s effect looked more pronounced in patients with mild Alzheimer’s than in those with moderate disease.
“The improvement in ADAS-Cog over 1 year in mild patients taking simufilam is well outside the expected range of historic placebo decline rates from numerous other studies,” said Suzanne Hendrix, who leads the external consulting firm tasked with analyzing the efficacy results.
COVID-19 (12%), urinary tract infection (10%), and headache (9%) were the three treatment-emergent adverse events found in 7% or more study participants. However, there were trial discontinuations with consent withdrawal (N=14), adverse events (N=13), and patient non-compliance (N=7) cited as the top three reasons for the decision.
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Cassava Sciences falls 17% after reporting mid-stage data for Alzheimer’s candidate