S
Shots:
- Amylyx has dosed the first participant in its pivotal P-III (LUCIDITY) study of avexitide (90mg) for post-bariatric hypoglycemia (PBH), with recruitment completion expected in 2025 and topline data in the H1’26
- The P-III (LUCIDITY) study evaluating avexitide (QD) vs PBO in ~75 PBH patients post Roux-en-Y gastric bypass surgery includes a 6wks. screening period, 3wks. run-in period and 16wks. treatment period and is conducted across ~20 US sites; FDA-endorsed 1EP is the reduction in Level 2/3 hypoglycemic events through 16wks.
- Avexitide, a GLP-1 receptor antagonist with the US FDA’s BTD and ODD, showed consistent, dose-dependent reductions in hypoglycemic events across five prior PBH Studies
Ref: Amylyx | Image: Amylyx
Related News:- Amylyx Pharmaceuticals’ AMX0035 Gains the EC’s Orphan Drug Designation to Treat Wolfram Syndrome
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
