Trevi Therapeutics (TRVI) Stifel 2024 Healthcare Conference summary

Pipeline and clinical focus

• Lead program targets chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough, both with significant unmet needs and market potential exceeding $1 billion each.

• Phase 2b trial in IPF chronic cough is ongoing, with a parallel Phase 2a proof-of-concept study in refractory chronic cough; two Phase 1 studies are also underway for respiratory physiology and human abuse potential.

• IPF chronic cough data showed a 75% reduction in cough frequency, with strong statistical significance and broad patient response.

• The drug acts on both central (brainstem) and peripheral (lung) pathways, targeting kappa agonist and mu antagonist opioid receptors, and is unscheduled due to its mechanism.

• Enrollment in IPF trials has been strong, with the patient population being rare but accessible due to the study's focus and design.

Clinical trial design and upcoming milestones

• The ongoing Phase 2b IPF trial uses a six-week parallel arm design to determine optimal dosing for Phase 3, with a built-in sample size re-estimation at 50% enrollment, expected in December.

• The refractory chronic cough (RCC) Phase 2a trial is fully enrolled, with top-line data expected in Q1; the IPF trial (CORAL) will report in the first half of the year.

• The RCC trial stratifies patients by cough frequency to assess efficacy across a broader population, aiming to support inclusion of all severity levels in future studies.

• Human abuse potential (HAP) study is required by updated FDA guidance and uses recreational opioid abusers to assess drug likability compared to a Schedule IV drug.

• A respiratory physiology study is underway to address FDA concerns about respiratory depression, especially in patients with sleep-disordered breathing.

Strategic and financial outlook

• Both IPF and RCC represent large, high-value opportunities; the company plans to focus on specialty markets and third-line therapy for RCC if data are positive.

• Total cost for advancing both programs (Phase 2b in RCC and two Phase 3s in IPF) is estimated at $125–$150 million.

• Current cash runway extends into the second half of 2026, sufficient to complete ongoing studies; additional funding will be sought for later phases.

• There is significant strategic interest from industry partners in both IPF and RCC, with ongoing discussions pending upcoming data releases.

• The company has deprioritized other indications, such as itch, to focus resources on cough-related programs.