Anavex Life Sciences Corp (AVXL)

[nidan7500]

This pr from today has a few key clues IMO. AVXL is (IMO) competitive in trials w/other international BP.

The AD target market is highly competitive as several other pharma companies like Anavex Life Sciences AVXL, Biogen BIIB and Roche RHHBY have their drugs targeting the AD indication. The Alzheimer’s drugs of these companies have either recently been approved for use or are in late-stage development.

Earlier this month, the FDA approved Biogen/Eisai’s Leqembi (lecanemab) under the accelerated approval pathway for the treatment of early AD. The approval was based on data from a mid-stage study which showed that treatment with the Biogen drug reduced the accumulation of amyloid beta (Aß) plaque in the brain. Biogen/Eisai priced Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year.

Last November, Rocheannounced the failure of the GRADUATE I and II studies, evaluating its monoclonal antibody gantenerumab in early AD. The studies failed to meet their primary endpoint of slowing clinical decline. Patients treated with Roche’s gantenerumab showed a slowdown of clinical decline in GRADUATE I and GRADUATE II, which was not statistically significant. Per Roche, the level of beta-amyloid removal was lower than expected.

Last month, Anavex Life Sciences reported positive topline data from a phase IIb/III study on its lead pipeline candidate ANAVEX 2-73 (blarcamesine) in AD indication. The ANAVEX 2-73-AD-004 study achieved its primary and key secondary endpoints. Data from the study showed that study participants who received ANAVEX 2-73 were 84% more likely to have improved cognition than those who were administered a placebo. Patients treated with ANAVEX 2-73 were 167% more likely to improve function than those receiving a placebo. The treatment also showed a statistically significant reduction in cognitive decline at the end of treatment by 45% compared with the placebo.