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Cassava Sciences Shares Fall On Phase 2 Alzheimer’s Trial Results

Cassava Sciences Shares Fall On Phase 2 Alzheimer's Trial Results

Editor’s note: The headline of this story has been updated to more accurately reflect the results of the Cassava Sciences Phase 2 trial for simufilam. 

  • Cassava Sciences Inc SAVA announced topline Phase 2 results for simufilam, its oral drug candidate for Alzheimer’s disease dementia. 
  • Study participants were administered open-label simufilam tablets 100mg twice daily for one year or more. Endpoints were measured at baseline (study entry) and month 12.
  • In the mild sub-group, ADAS-Cog (cognitive scale) scores improved, from 15.0 (±6.3) to 12.6 (±7.8)
  • In the moderate sub-group, ADAS-Cog scores worsened, from 25.7 (±9.2) to 30.1 (±13.1). Investors are probably reacting to this.
  • MMSE scores (cognitive impairment) changed from 21.5 (±3.6) – 20.2 (±6.4).
  • NPI10 scores (symptom Severity and Distress score) changed from 3.2 (±4.6) to 2.9 (±4.6).
  • Simufilam 100 mg twice daily was safe and well-tolerated. There were no drug-related serious adverse events. 
  • CSF biomarkers of disease pathology, t-tau, and p-tau181, decreased by 38% and 18%, respectively. CSF biomarkers of neurodegeneration, neurogranin, and neurofilament light chain decreased by 72% and 55%, respectively.
  • CSF biomarkers of neuroinflammation, sTREM2, and YKL-40, decreased by 65% and 44%.
  • Cassava Sciences is evaluating simufilam tablets for Alzheimer’s disease dementia in two Phase 3 studies. 
  • Most recently, FDA struck off  Eli Lilly And Co’s LLY donanemab for early symptomatic Alzheimer’s disease due to the limited number of patients. The agency asked for additional data. 
  • Price Action: SAVA shares are down 19.10% at $29.48 on the last check Tuesday.
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Written by biedex markets