Anavex Life Sciences Corp (AVXL)

[nidan7500]

So, how did we get from this upside post a few weeks ago to today. We had encouraging news and were looking positive. What did I miss? TIA . I thought Timo was doing great things....

Sunday, February 18, 2024 11:58:07 PM
Post# of 453137
AD/PD 2024 presentation on 3/9 in Lisbon, Portugal
Presenter: Timo Grimmer (Germany)
Lecture Time 09:10 - 09:25

Thanks to Veliger at Stocktwits.
$AVXL I'm hopeful the peer review may precede the 3/9 AD/PD Conference in Lisbon.
https://cslide.ctimeetingtech.com/adpd24/attendee/confcal/session/calendar?q=Anavex

Abstract
Aims
To assess in early Alzheimer’s disease (AD) patient’s efficacy and adverse events of blarcamesine (ANAVEX®2-73), an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) designed to exert neuroprotection through restoration of cellular homeostasis.

Methods
ANAVEX®2-73-AD-004 48-week study was an international, double-blind, multicenter, placebo-controlled Phase 2b/3 clinical study. 508 patients with AD were randomized to blarcamesine or placebo. The clinical outcomes (primary, secondary, and exploratory) included ADAS-Cog13, ADCS-ADL, CDR-SB, and CGI-I, which were analyzed using a mixed model for repeated measures (MMRM) and biomarkers from the A/T/N spectrum, plasma Aß42/40 ratio and brain volume measured by MRI.

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.

anavex_mri.jpg

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.