Anavex Life Sciences Corp (AVXL)

[Investor2014]

A little flashback may be in order for the old protein misfolding to get things back in the appropriate context. Everything said here will only be history in case Anavex secures full EMA approval as applied for. In that case please do feel free to lay into anything and everything I've posted to the contrary - I'll just be elated to have been proven wrong and celebrate it too.

Anavex Life Sciences Reports Fiscal 2023 First Quarter Financial Results

On December 1st, 2022, the Company announced, in a late breaking oral presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) Congress 2022, the top line data of its randomized, double-blind, multicenter, placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s disease. The trial met both its co-primary and key secondary endpoints, showing statistically significant and clinically meaningful improvement in cognition and function as measured by ADAS-Cog, ADCS-ADL, and CDR-SB, respectively.

The statement in red above turned out to be untrue no matter how much people feel like crying FUD and WRONG or applying any number of emoji, but please be my guest,. Perhaps also first read the rest of the quoted history.

Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study.

Well Missling & Co did not do as they wrote here. Why not we may never know if EMA approval is granted and no one will care much, including me. If EMA approval is not granted that statement will come up for serious criticism completely in line with what I and a few others are very picky about and call pound foolish and pennywise. Let's hope for the best outcome.

Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease

The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. 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 Alzheimer’s disease.

The bit in red clearly shows that this "The trial met both its co-primary endpoints" was untrue! - Yeah I know the whole FDA Draft Guidance debate etc. but that does not make the original misstatement any more correct.

Now back to the point - imho opinion the company would have been prudent to "proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study" as this would save time and money in the event that EMA approval is not granted without a confirmatory trial. Another trial is still likely required for FDA approval and/or to expand the label (whatever it may be) to a apply to a wider and more diverse population of AD patients.

Hoping the best and fearing the worst.

INV2014