Trevi Therapeutics (TRVI) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Key presentations and clinical data

• Highlighted strong phase II data in idiopathic pulmonary fibrosis (IPF) cough, showing a 75% reduction in cough frequency within three weeks and statistically significant results across all endpoints.

• Emphasized the unique mechanism of action as a kappa agonist and mu antagonist, differentiating from other opioids and targeting both central and peripheral pathways.

• Noted broad efficacy in hypersensitivity disorders, including severe pruritus and chronic cough, with a favorable safety profile and no tachyphylaxis observed in over 1,000 subjects.

• Discussed the competitive landscape, with many prior failures in IPF and refractory chronic cough, and positioned the drug as addressing both central and peripheral mechanisms.

• Detailed the phase II crossover study design, objective cough monitoring, and robust efficacy in both antifibrotic-treated and untreated patients.

Pipeline updates and upcoming milestones

• Phase II-B CORAL study in IPF cough is ongoing, focusing on dose-ranging and includes a sample size re-estimation at mid-enrollment, with a key interim readout expected by year-end.

• Refractory chronic cough (RCC) RIVER study is nearing full enrollment, with data expected in late 2024 or early 2025, aiming to demonstrate efficacy in both moderate and severe coughers.

• Additional phase I studies on respiratory physiology and human abuse potential are underway, with results anticipated by year-end.

• Strong cash position of nearly $70 million, expected to fund operations through early 2026, covering all major data readouts.

Commercial and strategic considerations

• Specialty pricing for IPF is expected to set the benchmark for future indications, with RCC targeted next and a focus on the most severe, treatment-resistant patients.

• The drug's mechanism may allow for broader application in neurological coughs, but initial focus remains on IPF and RCC due to company size and resource allocation.

• Dose titration is used in all studies to optimize tolerability, with discontinuation rates in line with other centrally acting drugs.

• Long-term potential exists for expansion into other chronic cough indications, but not for productive coughs related to infections.