Graig Suvannavejh's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q3 2024
Question
Graig Suvannavejh of Mizuho Securities asked for the rationale behind using a composite Level 2 and Level 3 hypoglycemia endpoint for the avexitide Phase III trial, noting a belief that the prior sponsor focused on Level 3. He also asked for the criteria for the go/no-go decision on the PSP trial after its interim analysis.
Answer
Dr. Camille Bedrosian, Chief Medical Officer, clarified that the composite endpoint is well-established in diabetes trials and captures all clinically meaningful events. Co-CEO Justin Klee added that strong effects were seen on both Level 2 and 3 events in prior studies. For the PSP trial, Dr. Bedrosian stated the decision will be based on clear clinical activity, primarily the change in PSPRS score versus placebo, along with biomarker data.