On Wednesday, Anavex Life Sciences Corp. (NASDAQ:AVXL) announced new findings for blarcamesine, an oral small molecule for early Alzheimer's disease.
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New data demonstrate continued long-term benefit from oral blarcamesine compared to the decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) control group.
Data
Externally matched control participants from the ADNI database were compared with participants over the 144 weeks of ANAVEXÃ2-73-AD-004 and its ATTENTION-AD (ANAVEXÃ2-73-AD-EP-004) open-label extension (OLE) Phase 2b/3 trial.
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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 â2.68 points.
ADAS-Cog13's total score ranges from 0 to 85, with higher scores indicating increased cognitive impairment.
Over the course of the open-label extension study at 96 weeks, statistically significant differences in mean change in ADAS-Cog13 total score were observed of â6.41 points.
The difference between groups continues to increase at 144 weeks (ADAS-Cog13 total score difference of â12.78 points).
In the Phase 2b/3 trial, oral blarcamesine resulted in 77.4 weeks (approximately 17.8 months) of time saved in the ITT population compared to the ADNI control group.
';Time saved' refers to the estimated amount of time a treatment delays the progression of the disease.
The clinical trial data on blarcamesine also confirmed the upstream mechanism of blarcamesine, restoring impaired autophagy as an early event, preceding amyloid-beta and tau.
Per data released in July, Anavex Life Sciences shared the findings for blarcamesine that demonstrated up to 84.6 Weeks (19.5 Months) of ';time saved' by the early-start analysis.
AVXL Price Action: Anavex Life Sciences shares were up 2.10% at $8.27 during premarket trading on Wednesday, according to Benzinga Pro data.
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