- The stock price of Cassava Sciences Inc (NASDAQ: SAVA) fell by over 25% during intraday trading. These are some details you should know.
The stock price of Cassava Sciences Inc (NASDAQ: SAVA) fell by over 25% during intraday trading. There is speculation that this event is being triggered by the concept of “buy the rumor, sell the news.”
Today Cassava Sciences had announced positive biomarker data and clinical data from an interim analysis of an open-label study of simufilam, the company’s investigational drug for the treatment of Alzheimer’s disease.
In a clinical study funded by the National Institutes of Health (NIH), simufilam had significantly improved cognition in Alzheimer’s patients with no safety issues. And simufilam improved all measured biomarkers in patients with Alzheimer’s disease following 6 months of open-label treatment and there were no placebo effects.
Simufilam had improved cognition scores 3.0 points on ADAS-Cog11, an 18% mean improvement, baseline to month 9 (p<0.001). And this interim analysis summarizes clinical data from the first 50 patients with mild-to-moderate Alzheimer’s disease who completed 9 months of open-label simufilam treatment.
Cassava Sciences said it believes today’s data is the first report of significant cognitive improvements at 9 months that also track with robust improvements in biomarkers in patients with Alzheimer’s.
Alzheimer’s is known as a progressive disease. And cognition will always decline over time. In patients with mild-to-moderate Alzheimer’s disease, cognition scores decline over 4 points on ADAS-Cog over 9 months with over 90% certainty (source: Disease Progression Meta-analysis Model in Alzheimer’s disease – Ito, et al., Pfizer Global Research – Alzheimer’s & Dementia 6 (2010) 39-53)
Simufilam had improved ADAS-Cog scores in 66% of patients at 9 months. And an additional 22% of patients declined less than reported in the scientific literature at 9 months. The cognition outcomes suggest simufilam’s treatment effects were broad-based.
“Six months of simufilam treatment robustly improved brain biomarkers. In this same study simufilam also improved cognition. These data suggest simufilam has potential to provide durable treatment effects for people living with Alzheimer’s.”
“We are very pleased with the overall consistency of data. Simufilam improved cognition, biomarkers, and behavior, a triple-win for study participants. These clinical data combined with a clean safety profile and easy oral administration suggest highly encouraging and durable treatment effects for people living with Alzheimer’s disease.”
— Remi Barbier, President & CEO
“Today’s data with simufilam suggests disease modification. It appears the drug’s unique mechanism of action has potential to provide transformative treatment benefits following 9 months of dosing.”
— Nadav Friedmann, PhD, MD, Chief Medical Officer
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