NEW HAVEN, Conn., June 2, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced that it has commenced an underwritten public offering of $100,000,000 of shares of its common stock. All of the shares in the offering are being offered by ...

Trevi Therapeutics, Inc. TRVI revealed topline results on Monday from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) (N=165).The primary endpoint in the CORAL trial was achieved, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at week six.Also Read: Trevi Therapeutics Reveals Positive Data From Mid-Stage Study For Chronic Cough Candidate, Stock JumpsThe 108 mg BID, 54 mg BID and 27 mg BID dose gr ...

Summary 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.

Controlling cough where it countsTM Positive Topline Results from Phase 2b Trial of Haduvio in Patients with IPF Chronic Cough (CORAL) June 2, 2025 Nasdaq: TRVI Forward Looking Statement Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation regarding matters that are not historical facts are "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncer ...

Haduvio met the primary endpoint with statistically-significant reductions in 24-hour cough frequency across all dose groups (108 and 54 mg BID p<0.0001; 27 mg BID p<0.01); a -43.3% placebo-adjusted change from Baseline was achieved at the 108 mg BID dose group  Patients saw a rapid reduction in 24-hour cough frequency at Week 2, the first time point measuredHaduvio was generally well-tolerated at all doses; discontinuation rates due to adverse events were similar in the Haduvio and placebo groups, 5.6% and ...

Core Insights - Trevi Therapeutics, Inc. is set to announce topline results from the Phase 2b CORAL trial of its investigational therapy Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) during a conference call on June 2, 2025 [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine extended-release) for chronic cough treatment in patients with IPF and refractory chronic cough (RCC) [4] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and RCC [4] - The mechanism of Haduvio involves acting on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors crucial for cough control [4] Industry Context - Chronic cough affects up to 85% of the IPF population, with approximately 140,000 patients in the U.S. suffering from IPF [3] - Patients with chronic cough may experience up to 1,500 coughs per day, leading to significant declines in their quality of life and increased risks of disease progression, death, or lung transplant [3] - Currently, there are no approved therapies for chronic cough in IPF patients, and existing off-label treatments offer minimal benefits [3]

NEW HAVEN, Conn., May 29, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced that senior management will be participating in the following conferences in June.American Cough ConferenceJune 6 – 7, 2025, Dulles, VirginiaOral Presentat ...

NEW HAVEN, Conn., May 20, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced additional analyses from the Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66). In March 2025, the Company announced positive t ...

Shares of Trevi Therapeutics, Inc. (TRVI) have gained 4.1% over the past four weeks to close the last trading session at $6.46, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $19.06 indicates a potential upside of 195.1%.The average comprises eight short-term price targets ranging from a low of $11 to a high of $29, with a standard deviation of $6.01. While the lowest estimate ...

Trevi Therapeutics Inc (TRVI) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Jennifer Good - Co-Founder, CEO, President & DirectorLisa Delfini - Chief Financial OfficerAnnabel Samimy - Managing DirectorJames Cassella - Chief Development OfficerJohn Gionco - Equity ResearchDebanjana Chatterjee - DirectorMayank Mamtani - Senior Managing DirectorFarrell Simon - Chief Commercial Officer Conference Call Participants Faisal Khurshid - Senior Research Analyst - Emerging ImmunologyLeland Gershe ...