Anavex Life Sciences Corp (AVXL)

[nidan7500]

ACE11-

RESULTS

The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48
weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226)
for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early AD.
In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P
= 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while
MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing
treatment to placebo.

CONCLUSIONS

Among participants with early symptomatic AD, blarcamesine was generally safe, well tolerated and
significantly slowed clinical progression at 48 weeks, which is also corroborated by biomarkers from the
A/T/N spectrum, including plasma Aß42/40 ratio increase and reduction of brain atrophy in several key
regions of the brain measured by MRI.
ClinicalTrials.gov Identifier: NCT03790709.

This trial presents RWE and RWD w/stat text is powerful method...RWE-RWD does MATTER.