Trevi Therapeutics (TRVI) investor relations material

Company overview and strategic focus

• Focused on chronic cough with three main indications: IPF cough, other interstitial lung disease cough, and refractory chronic cough.

• Only active program left in these cough indications, presenting a significant commercial opportunity.

• Chronic cough represents a large unmet need, with IPF affecting about 140,000 patients, 85% of whom have cough.

• Refractory chronic cough market estimated at 2–3 million patients, with a specialty focus on the most refractory cases.

• Commercial strategy targets specialty centers and community pulmonologists, leveraging synergy across indications.

Clinical development and trial design

• Lead asset nalbuphine targets both peripheral and central mechanisms of cough, differentiating it from prior failed approaches.

• Phase IIb CORAL study showed a 36% reduction in cough versus placebo at the optimal 54 mg BID dose, with no added benefit at higher doses.

• Phase III OCEAN-1 (52-week safety, 24-week efficacy) and OCEAN-2 (12-week efficacy) trials are underway or starting soon, powered for key endpoints.

• Titration strategy refined to mitigate early, transient CNS and GI side effects, with a week-long QD dosing before escalation.

• Objective cough monitoring validated with high inter-rater reliability, leveraging industry advances in device validation.

Regulatory and intellectual property

• Method of use patent for nalbuphine in chronic cough and IPF extends to 2039, with efforts to expand protection to 2046–2047.

• FDA alignment on primary and key secondary endpoints, with patient-reported outcomes (cough severity, breathlessness) central to approval strategy.

• No composition of matter patent due to drug age, but broad method and label claims pursued.