Anavex Life Sciences Corp (AVXL)

[abew4me]

Anavex's website still shows that they met all end points. (see below)


ANAVEX®2-73 (blarcamesine) Meets Co-Primary and Key Secondary Endpoints for Patients with Early Alzheimer’s Disease

• ANAVEX®2-73 (blarcamesine) treatment slowed decline of cognition and function in patients with early Alzheimer’s disease over 48 weeks
• ANAVEX®2-73 (blarcamesine) treatment reduced cognitive decline by 45%, measured by ADAS-Cog, as compared to placebo, representing a treatment difference in mean score change of -1.85 points (p=0.033) over 48 weeks
• Patients treated with ANAVEX®2-73 had 1.84 times higher odds, or likelihood, to improve cognitively compared to placebo, with an ADAS-Cog score threshold of -0.5 points or better [Odds Ratio = 1.84 (p = 0.015)] and had 2.67 times higher odds, or likelihood, to improve function with an

ADCS-ADL score threshold of +3.5 points or better compared to placebo [Odds Ratio = 2.67 (p = 0.0255)]
• Compared to placebo, ANAVEX®2-73 (blarcamesine) reduced clinical decline of cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by CDR-SB
• ANAVEX®2-73 (blarcamesine) was generally safe and well tolerated Next Steps
• Publish full analyses, including MRI data, prespecified biomarkers of response as well as Whole Exome Sequencing DNA data and full mRNA exome expression data collection data on biomarkers of neurodegeneration in a peer-reviewed medical journal
• Continue open-label extension study ATTENTION-AD to follow participants over 96 weeks
• Meet with regulatory authorities to discuss data with aim to bring this therapy to patients in Europe, Asia-Pacific, and the U.S., including potential Accelerated Approval Pathway based on newly available preliminary efficacy results of surrogate biomarkers
Odds Ratio of ADAS-Cog meaningful improvement in cognition at threshold of -0.5 points or less (90% CI)

Improvement
-1 0 1 2 3
ODDS RATIO
Odds Ratio of ADCS-ADL meaningful improvement in function at threshold of +3.5 points or higher (90% CI)
P = 0.015
1.839 (1.17, 2.94)
-0.5 0
1 2
3 4 5 6
ODDS RATIO
Improvement
P = 0.0255
2.67 (1.17, 6.13)
17

https://www.anavex.com/_files/ugd/79bcf7_97da6311c3b643bea8e9a6659bb51422.pdf