Finally some good news on the treatment of early Alzheimer's disease

Lane Simonian

This afternoon, Anavax Life Sciences announced results from its phase 2b/3 clinical trial for early Alzheimer's disease and the news was good.

ANAVEX®2-73 (BLARCAMESINE) PHASE 2B/3 STUDY MET PRIMARY AND KEY SECONDARY ENDPOINTS,
SHOWING STATISTICALLY SIGNIFICANT REDUCTION OF CLINICAL DECLINE IN GLOBAL CLINICAL STUDY OF PATIENTS WITH EARLY ALZHEIMER’S DISEASE

 

Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function as Measured by ADAS-Cog and ADCS-ADL
Key Secondary Endpoint CDR-SB Also Met, Demonstrating Statistically Significant Results
Plan to Meet with Regulatory Authorities to Determine Next Steps

 

ANAVEX®2-73 demonstrated visible improvement in patients with Alzheimer’s disease. Patients treated with ANAVEX®2-73 were 84% more likely, to have improved cognition by ADAS-Cog score change of -0.50 points or better from baseline to end of treatment than patients on placebo, Odds Ratio = 1.84 (p = 0.015). On average, patients, who improved cognitively with ANAVEX®2-73 treatment, improved by ADAS-Cog cognition score of -4.03 points. ANAVEX®2-73 treatment was 167% more likely to improve function compared with placebo, at a clinically meaningful improvement of ADCS-ADL score change of +3.5 points or better, Odds Ratio = 2.67 (p=0.0255). This reflects a robust improved and clinically meaningful outcome in cognition and function from baseline.

https://www.anavex.com/post/anavex-2-73-blarcamesine-phase-2b-3-study-met-primary-and-key-secondary-endpoints

For most patients with early Alzheimer's disease, blarcamesine at the highest dose led to improvements in cognition and activities of daily living at 48 weeks.  Long-term data for the drug at 148 weeks is limited to 8 patients, but a couple showed improvement and the other six declined by less than expected.  Blarcamesine does not appear to help those with moderate to severe Alzheimer's disease.  

The FDA now has to decide what to do with the results.  One action would be to approve the drug for sale but to require at least one more clinical trial.