Anavex Life Sciences Corp. (NASDAQ: AVXL) shares were lower in the first hour Wednesday. The company, a clinical-stage biopharmaceutical concern focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced new findings for blarcamesine, an oral small molecule for the potential treatment of early Alzheimer’s disease.
New data demonstrate continued long-term benefit from oral blarcamesine compared to decline observed in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) control group.
Externally matched control participants from the ADNI database were compared with participants over the 144-week period of ANAVEX2-73-AD-004 and its ATTENTION-AD (ANAVEX2-73-AD-EP-004) open-label extension (OLE) Phase IIb/III trial. For ADAS-Cog13, total score ranges from 0 to 85 with higher scores indicating increased cognitive impairment.
In the intent-to-treat (ITT) population, significantly less cognitive decline was observed for the blarcamesine participants compared to the ADNI control group at 48 weeks with a significant, and clinically meaningful difference in mean change from baseline ADAS-Cog13 total score of −2.68 points (p < 0.0001).
Over the course of the open-label extension study at time point 96 weeks, these two groups diverged sharply, with statistically significant differences in mean change in ADAS-Cog13 total score at 96 weeks of −6.41 points (p < 0.0001). The difference between groups continues to increase at 144 weeks (ADAS-Cog13 total score difference of −12.78 points; p < 0.0001).
AVXL shares gave back 14 cents to $7.97.
