Emma Seymour's questions to Prothena Corporation PLC (PRTA) leadership • Q4 2024
Question
Emma Seymour of Piper Sandler inquired about the best-case and base-case scenarios for the Phase III AFFIRM-AL trial's primary and secondary endpoints, and requested more detail on the commercial opportunity for birtamimab in AL amyloidosis.
Answer
President and CEO Gene G. Kinney explained that the significant unmet need in AL amyloidosis means achieving the FDA Special Protocol Assessment (SPA) success criteria of a p-value ≤ 0.10 on the all-cause mortality endpoint would represent a best-case scenario. COO Brandon Smith added that the market is established with a consolidated prescriber base, projecting birtamimab as a multi-billion dollar global opportunity due to the demand for a therapy that improves early survival.