No Decline in Cognition Scores in Patients with Mild Alzheimer's Disease Who Received Simufilam Continuously For 24 Months

• ADAS-Cog Scores Were Stable in a Group of Patients with Mild Alzheimer’s Who Received Drug Candidate Simufilam Continuously, Baseline to Month 24.
  
• Mild Alzheimer’s Patients Who Received Simufilam Non-Continuously Declined a Group Average of 1 Point on ADAS-Cog, Baseline to Month 24.
  
• Oral Simufilam Safe, Well-Tolerated.
  

AUSTIN, Texas, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today reported top-line results of a two-year clinical safety study of simufilam, an investigational oral drug for the proposed treatment of Alzheimer’s disease dementia. The study enrolled over 200 patients with mild to moderate Alzheimer’s and consisted of two open-label treatment phases and a randomized, placebo-controlled withdrawal phase. Average changes in ADAS-Cog scores, baseline to month 24, indicate the following:

• Patients with mild Alzheimer’s disease who received simufilam treatment continuously for two years (n=47) had no decline in ADAS-Cog scores (± 1.51 SE) as a group.
• Patients with mild Alzheimer’s who received simufilam treatment non-continuously (n=40) declined 1 point on ADAS-Cog (± 1.65 SE) as a group. Non-continuous treatment consisted of one year on open-label drug, six months on placebo and six months back on open-label drug.
• In patients with mild Alzheimer's, the largest separation between the continuous and non-continuous treatment groups occurred at the end of the 6-month randomized, placebo-controlled withdrawal phase.
• Patients with moderate Alzheimer’s who received simufilam treatment continuously for two years (n=32) declined 11.05 points on ADAS-Cog (± 1.91 SE) as a group.

“We’re fighting Alzheimer's disease by testing simufilam, a new type of drug that has a completely different mechanism of action from monoclonal antibody drug treatments,” said Remi Barbier, President & CEO. “Stable ADAS-Cog scores over 2 years is clearly a desirable clinical outcome in Alzheimer’s. Our data in mild patients may emphasize the importance of treating patients early in the disease.”

This was a 24-month safety study (NCT04388254). It included a pre-specified exploratory efficacy endpoint of mean change in ADAS-Cog11 scores. The study enrolled over 200 patients with mild-to-moderate Alzheimer’s disease (MMSE 16-26) who were recruited from 16 U.S. clinical sites.

The safety study was conducted in three continuous phases:

• a 12-month, open-label treatment phase, followed by
• a 6-month randomized, placebo-controlled withdrawal phase¹, followed by
• 6 additional months of open-label treatment.