Emma Seymour's questions to PROTHENA CORP PUBLIC LTD (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 for birtamimab, and requested more detail on the commercial opportunity in AL amyloidosis.
Answer
President and CEO Gene G. Kinney stated that achieving the FDA Special Protocol Assessment (SPA) success criteria of a p-value at or below 0.10 would represent a best-case scenario, given the significant unmet need for a therapy that improves survival. COO Brandon Smith added that birtamimab targets an established, multi-billion dollar global market with a consolidated prescriber base, expecting strong uptake due to its potential to demonstrate an early survival benefit.