Dan Akshit's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q1 2025
Question
Dan Akshit of Pareto Securities asked how Avexitide compares competitively to other potential entrants in the post-bariatric hypoglycemia (PBH) space, such as somatostatin analogs. He also inquired about the expected placebo response in the Phase III LUCIDITY trial.
Answer
Co-CEO Justin Klee emphasized Avexitide's strong position, noting it is in Phase III with FDA Breakthrough Therapy Designation based on five prior successful trials. Co-CEO Joshua Cohen reiterated that the designation implies a potential benefit over existing options, of which there are none approved. Regarding the placebo rate, Justin Klee stated that no meaningful placebo effect was seen in the Phase II study, but the Phase III trial is robustly powered to account for a potential placebo response regardless.