Replies to post #462135 on Anavex Life Sciences Corp (AVXL)

[Talon38]

Plex.....according to the agenda, Anavex will have an hour and a half for the presentation and questions, which is positive!

[falconer66a]

Blarcamesine Achieves Validity

In a recent posting I expressed my opinion that Anavex quietly had a lot important things happening and very positive developments should soon begin to be announced. The first of those just appeared, at the URL in the previous message.

On Sunday, July 28, 2024, that paper will be presented at the Alzheimer's Association International Conference in Philadelphia. This will validate both blarcamesine’s safety and efficacy in Alzheimer’s patients with early-stage Alzheimer’s disease.

The ability of blarcamesine to successfully treat four recognized Alzheimer’s disease severity metrics were assessed. The paper made this claim:

The blarcamesine group demonstrated improvement compared to the placebo group in all clinical endpoints at 48 weeks: when comparing least-squares mean (LSM) change in ADAS-Cog13 score (difference, -1.783 [95% CI, -3.314 to -0.251]; P = 0.0226), LSM change in ADCS-ADL score (difference, 1.019 [95% CI, -0.66 to 2.70]; P = 0.234), LSM change in CDR-SB score (difference, -0.456 [95% CI, -0.831 to -0.080]; P = 0.0175), and LSM change in CGI-I score (difference, -0.285 [95% CI, -0.474 to -0.095]; P = 0.0033).

All but the ADCS-ADL scores were statistically significant; not a result of chance. Those with expertise on each of these metrics are invited to state their significance in this trial.

There have been posted concerns that only a few minutes will be devoted or allowed for the presentation of this paper, which will diminish or hinder a proper understanding of the paper’s findings. But, when this Alzheimer’s conference ends the paper does not evaporate. There will be ample opportunity for Anavex to subsequently answer questions and present further data or comments on the topic.

Then, of particular interest and significance will be the publishing of the long-awaited peer-reviewed medical journal paper on this same topic. Let’s see if it, too, presents positive trial results of blarcamesine in the treatment of early-stage Alzheimer’s. If so, it will be a strong, second validation of the Anavex drug.

The referenced webpage and the new abstract are now available for public access and consideration. There will be lots of Alzheimer’s scientists reading the paper closely. Blarcamesine can no longer be swept under a rug of disbelief.

[rx7171]

A 90 minute prime time presentation should give a lot of detailed information we haven’t seen before.

[nidan7500]

Thanks plexrec for this link.

Any who have attended participated or supported the planning, preparation and/or presentation at a conference like this one recognize the hard work and precision required to get this important work done. Congrats and thanks to the entire AVXL presentation team and support staff for your hard work and dedication .

Those of us who have ever participated in one of these major conferences will value this dedication and the disciplined processes you have applied in getting AVXL to this point.

Congrats Dr.M. and AVXL team. WELL DONE.
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Blarcamesine in Early Alzheimer Disease Phase 2b/3 Randomized Clinical Trial

Sunday, July 28, 2024
4:15 PM - 5:45 PM
201 ABC (Pennsylvania Convention Center)
Theme
Drug Development
Abstract
Background:
There are no approved oral disease-modifying treatments for Alzheimer disease (AD). This study was intended to assess efficacy and safety 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 including autophagy enhancement.
Method:
ANAVEX®2-73-AD-004 is a multicenter (52 medical research centers/hospitals in 5 countries), randomized, double-blind, placebo-controlled, 48-week phase 2b/3 trial that enrolled 508 participants with early AD (mild cognitive impairment/mild dementia) from July 2018 to June 2021 (last patient visit in June 2022). Participants were randomized to receive blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks.
The co-primary cognitive and functional outcomes were the change in ADAS-Cog13 and ADCS-ADL scores from baseline to 48 weeks. Additional clinical outcomes include the secondary outcome CDR-SB and the exploratory outcome CGI-I. All clinical endpoints were analyzed using a mixed model for repeated measures (MMRM).
Result:
The blarcamesine group demonstrated improvement compared to the placebo group in all clinical endpoints at 48 weeks: when comparing least-squares mean (LSM) change in ADAS-Cog13 score (difference, -1.783 [95% CI, -3.314 to -0.251]; P = 0.0226), LSM change in ADCS-ADL score (difference, 1.019 [95% CI, -0.66 to 2.70]; P = 0.234), LSM change in CDR-SB score (difference, -0.456 [95% CI, -0.831 to -0.080]; P = 0.0175), and LSM change in CGI-I score (difference, -0.285 [95% CI, -0.474 to -0.095]; P = 0.0033). Participants with ≥1 serious treatment-emergent adverse events (TEAEs) occurred in 56 participants (16.7%) in the blarcamesine group and 17 (10.1%) in the placebo group. Common treatment-emergent adverse events included dizziness, which was mostly mild to moderate in severity.
Conclusion:
In this phase 2b/3 randomized clinical trial, we found that among participants with early AD, blarcamesine significantly slowed clinical progression on prespecified primary outcome global and cognitive measures at 48 weeks in the ITT population. These results suggest that blarcamesine may be an effective, safe, and novel scalable oral treatment for early AD.
Presenting Author
Marwan N. Sabbagh
Barrow Neurological Institute
Authors
William R. Chezem
Anavex Life Sciences Corp
Kun Jin
Anavex Life Sciences
Christopher U Missling
Anavex Life Sciences Corp.