Trevi Therapeutics(TRVI)2025-06-02 13:30Summary of Trevi Therapeutics Inc (TRVI) Update - June 02, 2025 Company Overview - Company: Trevi Therapeutics Inc (TRVI) - Focus: Development of Haduvio for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) Key Industry Insights - Chronic Cough in IPF: - Approximately 140,000 patients with IPF in the U.S. - Up to 85% of IPF patients report chronic cough, significantly impacting their quality of life [8][9] - No FDA-approved therapies for chronic cough in IPF patients [9][34] Core Findings from the CORAL Phase IIb Trial - Trial Results: - First positive results in a Phase IIb trial for chronic cough in IPF patients [10] - Dose-related response observed: - 60% reduction in cough frequency at the highest dose (108 mg BID) - 48% reduction at the lowest dose (27 mg BID) - Placebo-adjusted difference of 43% at the highest dose [11][21] - Majority of patients (approximately 60-65%) achieved a 50% or greater reduction in cough frequency [23] - Rapid onset of effect observed as early as week two [12][22] - Patient Reported Outcomes: - Significant improvements in cough frequency and severity reported by patients [24][26] - At week six, the 54 mg and 108 mg BID groups showed significant differences from placebo [25] - Safety Profile: - Low discontinuation rates: 5% for placebo and 5.6% for Haduvio [12][27] - Common adverse events included nausea, vomiting, and headache, consistent with previous studies [28] Future Development Plans - Phase III Program: - Plans to request an end of Phase II meeting with the FDA to align on the Phase III program for IPF chronic cough [35] - Anticipated initiation of a trial for chronic cough in non-IPF interstitial lung disease (ILD) by the end of 2025 [33] - Market Opportunity: - High unmet need in both IPF and non-IPF ILD chronic cough, with potential to double the market size [33][34] - Expected rapid uptake in physician prescribing due to lack of effective therapies [30] Competitive Landscape - Positioning: - Trevi aims to be best-in-class and first-in-class for chronic cough treatment in IPF [30] - Current off-label treatments are ineffective, highlighting the commercial opportunity for Haduvio [32] Additional Considerations - Patient Impact: - Chronic cough significantly affects patients' quality of life, leading to social isolation and reduced activity levels [42][43] - Immediate benefits of Haduvio could lead to high patient adherence [46][70] - Regulatory and Research Considerations: - Ongoing discussions with the FDA regarding study design and duration for Phase III trials [52][53] - Future data on patient-reported outcomes and safety will inform dosing strategies [97][108] This summary encapsulates the key points from the Trevi Therapeutics conference call, focusing on the company's advancements in treating chronic cough associated with IPF and the implications for future research and market positioning.