Amylyx Reports Strong Phase II Data for Avexitide in Post-Bariatric Hypoglycaemia

Amylyx Pharmaceuticals shared promising results for avexitide, its investigational GLP-1 receptor antagonist, from Phase II PREVENT and Phase IIb trials at ENDO 2025. In the Phase IIb study, a 90mg once-daily dose led to a 64% reduction in Level 2 and 3 hypoglycaemic events, with over half of patients experiencing no such episodes during treatment. This dose is being evaluated in the pivotal Phase III LUCIDITY trial, involving 75 post-bariatric hypoglycaemia (PBH) patients after Roux-en-Y gastric bypass.

New PK/PD data show the 90mg dose maintains 24-hour pharmacologic activity, supporting its efficacy. Lower doses, such as 45mg twice daily and 60mg once daily, also showed consistent benefits. Avexitide was well tolerated across all trials with a favourable safety profile.

LUCIDITY results are expected in H1 2026, with a commercial launch projected for 2027. Amylyx is also advancing AMX0114 for ALS in its Phase I LUMINA trial, which began dosing in April 2025.

14-07-2025