Amylyx Pharmaceuticals Says LUCIDITY Phase 3 Trial Met Its Primary Endpoint, Demonstrating 55% Reduction in Level 2 and Level 3 Hypoglycemic Events Vs. Placebo
LUCIDITY met FDA-agreed-upon primary endpoint; avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003)
LUCIDITY met all secondary endpoints showing consistent, highly statistically significant, and clinically meaningful reductions in Level 2 by self-monitoring of blood glucose (SMBG), Level 2 by CGM, and Level 3 hypoglycemic events
Avexitide was generally well-tolerated with a favorable safety profile
Amylyx plans to submit an NDA for avexitide with the FDA by year-end; avexitide has Breakthrough Therapy and Orphan Drug Designations by the FDA
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