Anavex Presents Results From Phase IIb/III Trial Of Blarcamesine In Alzheimer's Disease

(RTTNews) - Anavex Life Sciences Corp. (AVXL) presented results from the Phase IIb/III study showing that blarcamesine (ANAVEX 2-73), once daily orally, significantly slowed clinical decline in people with early Alzheimer's disease or AD.

According to the company, 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. 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 pre-specified 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 Aß42/40-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's safety profile indicates not requiring routine MRI monitoring, and given its differentiated mechanism of action, could represent a novel treatment that could be complementary to the currently approved anti-beta amyloid monoclonal antibody drugs.

Full regulatory submission of blarcamesine in Europe (EMA) is expected in the fourth-quarter 2024.

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