Chen Yang's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q3 2024
Question
Chen Yang of Bank of America inquired about the Phase III trial design for avexitide in PBH, asking what factors beyond the previous Eiger agreement are being considered and if there's potential for a readout earlier than 2026.
Answer
Dr. Camille Bedrosian, Chief Medical Officer, confirmed the trial design is being refined based on prior FDA discussions. She reiterated key elements: a 90mg dose, a primary composite endpoint of Level 2 and 3 hypoglycemia events, and a proposed 90-participant, 12-week study. She affirmed the timeline, expecting trial initiation in Q1 2025 with top-line data anticipated in 2026.