Cassava Sciences (NASDAQ:SAVA) announces final results from a 64-subject Phase 2b clinical trial evaluating lead candidate sumifilam (PTI-125) in Alzheimer’s disease (AD) patients.
Treatment with sumifilam produced statistically significant improvements in a range of AD-related biomarkers compared to placebo, the primary endpoint. The response rate, defined as patients who showed biomarker improvements, was 98%.
Sumifilam was safe and well-tolerated.
The positive outcome is a reversal of fortune for the study. In May, the company reported that the trial failed to achieve the primary endpoint due to high variability in biomarker data in the control group. It says the analysis, conducted by outside labs, is no longer valid.
Small molecule PTI-125 targets an altered form of filamin A, a scaffolding protein found throughout the body. A highly toxic form of the protein is present in the brains of AD sufferers which disrupts the normal function of neurons, leading to neurodegeneration and brain inflammation. PTI-125 is designed to restore the normal shape of filamin A in the brain, improving the function of multiple brain receptors and dampening neuroinflammation.
Development is ongoing.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
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