Shares of Cassava Sciences Inc. (SAVA), which closed at a 52-week high of $5.21 on Friday (Dec.27), are up a whopping 210% over the last 6 trading days.
Cassava Sciences is a clinical-stage biotechnology company developing PTI-125, a novel drug treatment for Alzheimer’s disease, and PTI-125Dx, an investigational diagnostic to detect Alzheimer’s with a simple blood test.
The lead drug candidate PTI-125 has a novel mechanism of action designed to restore the normal shape/function of Filamin A (FLNA), a scaffolding protein that misfolds in the brain with Alzheimer’s.
In a phase IIa study funded by the National Institutes of Health, the results of which were announced early in September of this year, treatment with PTI-125 for 28 days significantly reduced key biomarkers of neuroinflammation and neurodegeneration in all 13 patients, according to the Company.
Based on the phase IIa results that demonstrated a 100% response rate, Cassava Sciences initiated a phase IIb study of PTI-125, in Alzheimer’s patients the same month (September 2019). This study, supported by a research grant award from the National Institutes of Health, is designed to enroll about 60 patients with mild-to-moderate Alzheimer’s disease who will be dosed with PTI-125 100 mg, 50 mg, or matching placebo, twice daily for 28 continuous days.
The primary endpoint is an improvement in biomarkers of Alzheimer’s disease from baseline to Day 28. The results of the phase IIb study of PTI-125 in Alzheimer’s are expected in the fourth quarter of 2020.
The investigational diagnostic PTI-125Dx in blinded studies has detected more than a 10-fold separation between Alzheimer’s patients and age-matched normal healthy controls or young cognitive intact subjects.
Financials on September 30, 2019:
— Cash & Cash Equivalents: $17.8 million — Debt: None
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