Michael DiFiore's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q3 2024
Question
Michael DiFiore of Evercore ISI asked about the risk of hyperglycemia with avexitide, a GLP-1 antagonist. He also requested color on the FDA's clinical hold on AMX0114 and its potential impact on U.S. commercialization.
Answer
Dr. Camille Bedrosian, Chief Medical Officer, stated that avexitide restores homeostasis and has not caused hyperglycemia in prior studies. Co-CEO Justin Klee added it is well-tolerated. Regarding AMX0114, Dr. Bedrosian expressed confidence in its safety profile, noting a >10x safety margin and clearance from Health Canada. Mr. Klee mentioned a trend of first-in-human trials for RNA therapeutics occurring ex-U.S.