Shots:
- The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery
- Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly significant & clinically meaningful reductions in SMBG & CGM-measured Level 2 events & independently adjudicated Level 3 events
- Amylyx plans to submit an NDA for avexitide to the FDA by the end of 2026. The FDA has granted avexitide Breakthrough Therapy Designation for PBH, while the 32wk. LUCIDITY OLE & expanded access program remain ongoing
Ref: Businesswire | Image: Amylyx | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
