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On Sunday, Anavex Life Sciences Corp. (NASDAQ:AVXL) presented comprehensive results from the Phase 2b/3 study showing that blarcamesine (ANAVEX2-73), once daily orally, significantly slowed clinical decline in people with early Alzheimer’s disease (AD).
The data were presented at the 2024 Alzheimer’s Association International Conference (AAIC).
Blarcamesine significantly slowed clinical progression by 38.5% and 34.6% at 48 weeks in 50 mg and 30 mg groups vs. placebo, respectively, on the prespecified primary cognitive endpoint ADAS-Cog13.
As specified in the March 2024 FDA Guidance for Early AD, a sole cognitive measure can serve as the primary endpoint for early Alzheimer’s trials.
The protocol was designed with ADAS-Cog13 and ADCS-ADL as co-primary endpoints.
The functional co-primary endpoint, ADCS-ADL, was trending positive but did not reach significance at Week 48.
A possible explanation is that the ADCS-ADL scale is designed for AD with overt dementia and is less sensitive for early AD.
The prespecified key secondary composite endpoint CDR-SB, also recommended as an alternative primary endpoint for early AD in the new FDA guidance, is significant at both 30 mg and 50 mg at Week 48.
The findings are supported by biomarkers from the A/T/N spectrum, including plasma Aβ42/40-ratio and reduction of brain atrophy.
Blarcamesine significantly slowed brain atrophy in key regions of interest, including the whole brain by 37.6%, total grey matter by 63.5%, and lateral ventricles by 25.1%.
Blarcamesine demonstrated numerically superior clinical efficacy to approved therapies while also slowing neurodegeneration in early AD patients.
Blarcamesine’s safety profile indicates that routine MRI monitoring is not required.
The company says full regulatory submission of blarcamesine in Europe (EMA) is expected in the fourth quarter of 2024.
Earlier this year, Anavex Life Sciences provided an update on the Rett Syndrome program. The company reported topline results from the Phase 2/3 EXCELLENCE trial of 30 mg ANAVEX 2-73 in 92 pediatric patients.
After 12 weeks, the study showed improvement on the key co-primary endpoint Rett Syndrome Behaviour Questionnaire.
The other co-primary endpoint, the Clinical Global Impression–Improvement scale (CGI-I), which represents a less granular assessment by the site investigators using a seven-point scoring, was not met.
Price Action: AVXL stock is up 11.40% at $7.51 during the premarket session at last check Monday.
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