Trevi Therapeutics (TRVI) 24th Annual Needham Virtual Healthcare Conference summary

Key clinical developments

• Achieved positive efficacy in both IPF and RCC chronic cough, with rapid onset and strong placebo-adjusted reductions in cough frequency across trials.

• Phase II B CORAL trial in IPF cough is fully enrolled, with top-line data expected in Q2; sample size re-estimation confirmed adequate powering.

• RCC phase II A and crossover studies showed consistent, significant results across moderate and severe coughers, supporting a central mechanism of action.

• Adverse events were mainly GI and CNS-related, typically transient and manageable.

• Next steps include a phase II B dose-ranging study in RCC and potential expansion into other neurological cough indications.

Market opportunity and unmet need

• No approved therapies exist for RCC in the U.S.; current treatments are off-label and often inadequate or carry risks.

• RCC market estimated at 2-3 million patients, with an addressable U.S. market of about 1 million.

• IPF cough affects about 100,000 U.S. patients, with the market expected to grow to 200,000 by launch.

• IPF/ILD market is highly concentrated, enabling efficient commercial coverage.

Clinical and regulatory strategy

• Phase II B CORAL trial in IPF cough uses a parallel arm, dose-ranging design with 160 patients across 10 countries.

• If positive, plan to proceed to two pivotal phase III trials, each enrolling 150-200 patients, with a primary endpoint of cough reduction and one-year safety data.

• Expansion into other interstitial lung diseases (ILDs) planned via a basket trial approach.

• Human abuse liability studies and low-dose efficacy support a favorable risk-benefit profile and unscheduled status.