Jason Dorr's questions to Trevi Therapeutics Inc (TRVI) leadership • Q2 2025
Question
Jason Dorr from Oppenheimer & Co. Inc. asked about the key topics to be addressed in the upcoming end-of-Phase 2 FDA meeting for Haduvio in IPF cough and requested details on the planned trial for non-IPF ILD chronic cough.
Answer
Chief Development Officer James Cassella outlined that the FDA meeting will focus on aligning on the Phase 3 protocol, dose selection, and the required safety database size. For non-IPF ILD, he noted the trial will include patients with various underlying fibrotic diseases. CEO Jennifer Good added that the company's strategy for the non-IPF ILD trial has evolved to a parallel arm design to potentially accelerate the program.