Cassava's Phase 2 Results In Alzheimer's
Austin, Texas-based Cassava released top-line results from a Phase 2 study of its lead investigational asset PTI-125 that is being evaluated in patients with Alzheimer's disease that showed that study did not meet the primary endpoint.
The primary endpoint was a statistically significant effect of the investigational asset versus placebo on cerebrospinal fluid, or CSF, levels of tau protein and other biomarker assessments from baseline to day 28.
"The drug effects of PTI-125, if any, may have been masked in this study by high variability in levels of biomarkers of disease," the company said.
A secondary endpoint of CSF levels of IL1-beta, a core biomarker of neuroinflammation from baseline to day 28, was met, Cassava said. The drug was also found to be safe and well-tolerated.
Why It Matters For Cassava
PTI-125 is the only drug candidate in Cassava's pipeline, and the company was developing the asset with NIH funding.
Alzheimer's drug development has proved futile for many companies given the complexities involved.
"Today's top-line results disappoint and are not consistent with previous clinical experience for reasons that are unclear at the moment," President and CEO Remi Barbier said in a statement.
What's Next For Cassava
Cassava said it plans to thoroughly analyze the top-line data and to re-analyze CSF biomarkers from study participants to better understand the outcome of the study.
At last check, Cassava shares were tumbling 74.35% to $2.08.