Trevi Therapeutics (TRVI) investor relations material

Strategic focus and market opportunity

• Targeting difficult-to-treat chronic cough conditions with a differentiated mechanism acting both peripherally and centrally.

• Estimated $6 billion+ peak sales opportunity, focusing on idiopathic pulmonary fibrosis (IPF) and non-IPF interstitial lung diseases (ILD).

• Specialty sales model with plans to independently commercialize the therapy.

• Addressing a significant unmet need, as current antifibrotics do not alleviate cough symptoms.

Clinical development and efficacy data

• Phase II-B study in IPF-related cough showed statistically significant dose response and rapid onset of effect.

• About two-thirds of patients experienced a 50% reduction in cough frequency after six weeks.

• Adverse events were mostly mild to moderate, with similar discontinuation rates between drug and placebo.

• Efficacy and safety data published in JAMA, supporting further development.

Ongoing and planned clinical trials

• Two pivotal studies (OCEAN 1 and OCEAN 2) in IPF cough: OCEAN 1 (52 weeks, primary endpoint at 24 weeks, readout 1H 2028), OCEAN 2 (12 weeks, readout 2H 2027).

• Studies powered for multiple secondary endpoints, including breathlessness and cough bouts.

• Plans to expand into non-IPF ILD, targeting a total addressable population of 350,000 patients.

• FDA discussions scheduled for ILD trial initiation later this year.