Anavex Life Sciences Corp (AVXL)

[Hosai]

The abstract of the OLE presentation Timo Grimmer is doing is now viewable:

Aims
There are no approved oral small molecule therapies for treatment of early Alzheimer’s disease (AD). Blarcamesine is an orally bioavailable small molecule that acts as an agonist of the sigma-1 receptor (SIGMAR1) that enhances autophagy through SIGMAR1 activation and restoration of cellular homeostasis in early AD.
The ATTENTION-AD study was an up to 144-week open-label extension study of the Phase IIb/III double-blind placebo-controlled study ANAVEX2-73-AD-004, to evaluate the safety and efficacy of oral once daily blarcamesine in participants with early AD.

Methods
The delayed-start analysis was performed using Mixed effect Model Repeated Measures (MMRM) to evaluate effects of early treatment of blarcamesine. Comparisons were made between ‘Continued blarcamesine’ (early start) and ‘Placebo to blarcamesine’ (late start) for ADAS-Cog13 and ADCS-ADL.

Results
The delayed-start analysis for ADAS-Cog13 showed a significant difference between early and late start treatment groups at week 144 (LS mean difference -2.70, P = 0.0348), favoring the early start group and increasing up to week 192 (LS mean difference -3.83, P = 0.0165). The delayed-start analysis for ADCS-ADL showed a similar trend between early and late start groups at week 144 (LS mean difference +2.32 P = 0.125), increasing up to week 192 and reaching statistical significance (LS mean difference +4.30, P = 0.0206).

Conclusions
Blarcamesine-treated patients continue to accrue benefit through up to 4 years, as measured by co-primary endpoints ADAS-Cog13 and ADCS-ADL. Delayed start group does not catch up to early start group, reflecting importance of early treatment initiation. The results provide further support for the efficacy results in the pivotal phase IIb/III study. No new safety findings have been observed with continued blarcamesine treatment over three years with good comparative safety profile and no associated neuroimaging adverse events.

https://cslide.ctimeetingtech.com/adpd25/attendee/confcal/