Trevi Therapeutics (TRVI) Leerink Global Healthcare Conference 2026 summary

Strategic focus and recent progress

• Achieved strong Phase II data in IPF-related and refractory chronic cough, enabling Phase III preparation.

• End-of-Phase II FDA meeting provided positive feedback and alignment on Phase III trial design and endpoints.

• Lead indication is IPF-related chronic cough, with expansion plans into other interstitial lung diseases and refractory chronic cough.

• Anticipates NDA filing in approximately two and a half years, reflecting significant progress.

Phase III and regulatory pathway

• Phase III program will include two trials: one with a 52-week dosing and 24-week primary endpoint, another with a 12-week endpoint.

• Primary efficacy measured by objective cough monitoring; key secondary endpoints focus on patient-reported outcomes.

• FDA agreed on trial endpoints and secondary measures, including cough severity and quality of life.

• Powering assumptions include 2:1 randomization, 90% power, and a 20% discontinuation rate.

• Phase I studies will address drug-drug interactions, especially with nintedanib, and standard labeling requirements.

Timelines and future milestones

• 52-week Phase III study to start in Q2, second study in Q3, with 12-month enrollment for each.

• 12-week data expected by late 2027, with the larger study readout in 2028.

• Formal guidance on timelines to be provided in the coming months.