Core Insights - Trevi Therapeutics is advancing its investigational therapy Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), with plans to initiate a comprehensive Phase 3 program in the first half of 2026 [1][5]. Financial Performance - The company reported a net loss of $11.8 million for Q3 2025, an improvement from a net loss of $13.2 million in Q3 2024 [7][13]. - Research and development (R&D) expenses decreased to $10.1 million in Q3 2025 from $11.2 million in Q3 2024, primarily due to reduced clinical development costs [4][13]. - General and administrative (G&A) expenses increased to $3.8 million in Q3 2025 from $2.9 million in Q3 2024, attributed to higher professional fees and personnel-related expenses [6][13]. - The company ended Q3 2025 with $194.9 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2028 [1][4]. Clinical Development - Trevi Therapeutics is preparing to submit an End-of-Phase 2 meeting request to the FDA in Q4 2025 and plans to initiate its Phase 3 program in the first half of 2026 [2][5]. - The safety review committee for the Phase 1 TIDAL study concluded there were no safety signals, allowing for the completion of patient enrollment [5]. - Positive results from the Phase 2a RIVER trial were presented at major medical meetings, and a Phase 2b RCC study is planned for the first half of 2026 [5][9]. Market Opportunity - There are approximately 150,000 patients with IPF in the U.S., with two-thirds experiencing uncontrolled chronic cough, and around 228,000 patients with non-IPF interstitial lung disease, with 50-60% also suffering from uncontrolled chronic cough [9]. - RCC affects an estimated 2-3 million patients in the U.S., representing a significant unmet medical need as there are currently no FDA-approved therapies for these conditions [9].

Core Insights - Trevi Therapeutics, Inc. is advancing its investigational therapy Haduvio™ (oral nalbuphine ER) for chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC) [1][5] - Data from the Phase 2a RIVER trial will be presented at the European Respiratory Society (ERS) Congress 2025, highlighting the efficacy and safety of nalbuphine ER in treating RCC [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for chronic cough, with Haduvio being the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF and RCC patients [5][6] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors involved in chronic cough control [5] Clinical Trial Details - The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of nalbuphine ER in RCC patients, with treatment periods lasting 21 days and a primary endpoint focused on the mean change in 24-hour cough frequency [3][4] - The trial included a full analysis set (FAS) population, which consisted of patients who received at least one dose of the study drug and had objective cough count data [3] Market Need - RCC is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions, affecting approximately 2-3 million patients in the U.S. [4] - There are no FDA-approved therapies for RCC, indicating a significant unmet medical need in this patient population [4] Impact of Chronic Cough - Chronic cough in patients with IPF and non-IPF ILD is prevalent, with around 150,000 U.S. patients with IPF and 228,000 with non-IPF ILD, where 50-60% experience uncontrolled chronic cough [6] - The condition can lead to severe morbidity and a decline in quality of life, with patients potentially coughing up to 1,500 times per day [6]

Core Viewpoint - Trevi Therapeutics, Inc. is advancing its investigational therapy Haduvio™ for chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), with upcoming participation in key biotech conferences [1][2]. Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment [2][5]. - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for patients with IPF chronic cough and RCC [2][5]. Industry Context - Chronic cough affects up to 85% of patients with IPF, with approximately 150,000 patients in the U.S. suffering from this condition [3]. - Patients with chronic cough may cough up to 1,500 times per day, leading to severe health impacts, including disease progression and reduced quality of life [3]. - There are currently no approved therapies for chronic cough in IPF patients, and existing off-label treatments offer minimal benefits [3]. - Refractory chronic cough, affecting around 2-3 million patients in the U.S., is characterized by a persistent cough lasting over 8 weeks without approved therapies [4].

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]

Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [3][4] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials involving IPF and RCC patients [3][4] Industry Context - Chronic cough affects up to 85% of the IPF population, with approximately 150,000 IPF patients in the U.S. experiencing severe coughing, up to 1,500 times per day [4] - There are currently no approved therapies for chronic cough in IPF patients, and existing off-label treatments offer minimal benefits [4] - Refractory chronic cough, affecting around 2-3 million patients in the U.S., is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions, and it has no approved therapies [5] Upcoming Conferences - Trevi management will participate in several conferences in June 2025, including: - American Cough Conference on June 6-7, with an oral presentation on the RIVER trial [2] - CPDD 87th Annual Scientific Meeting on June 14-18, featuring a poster on the human abuse potential of nalbuphine [2] - BIO International Convention on June 16-19, with a corporate presentation scheduled for June 17 [3]

Core Insights - Trevi Therapeutics presented additional analyses from the Phase 2a RIVER trial of Haduvio, which showed a statistically significant reduction in 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p<0.0001) for patients with refractory chronic cough (RCC) [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and RCC [7] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF and RCC patients [7] Phase 2a RIVER Trial Details - The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled study with two treatment periods, each lasting 21 days, separated by a 21-day washout period [5] - The primary endpoint was the mean change in 24-hour cough frequency, assessed by an objective cough monitor at Day 21 [5] Refractory Chronic Cough (RCC) Insights - RCC affects approximately 2-3 million patients in the U.S. and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions [6] - There are currently no approved therapies for RCC in the U.S., making Haduvio a potentially significant treatment option [6] Efficacy and Safety Findings - Responder analyses indicated statistically significant reductions in 24-hour cough frequency at thresholds of 30%, 50%, and 75% for patients on Haduvio across all doses [8] - Patients reported significant improvement in the Leicester Cough Questionnaire at Day 21 for the 108 mg BID dose (p<0.0001) [8] - Adverse events were more frequently observed during the initial exposure to Haduvio, particularly at the 27 mg BID dose, but diminished over time [8]

Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [4][5] - Haduvio is the first therapy in clinical development to demonstrate a statistically significant reduction in chronic cough for both IPF and RCC patients [4] Market Need - Chronic cough affects up to 85% of the 140,000 U.S. IPF patients, leading to severe impacts on their quality of life, including social, physical, and psychological decline [5] - Refractory chronic cough, affecting approximately 2-3 million patients in the U.S., has no approved therapies and is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions [6] Upcoming Events - Trevi will participate in several investor conferences in April 2025, including: - 24th Annual Needham Virtual Healthcare Conference on April 7, with a corporate presentation by Jennifer Good, President and CEO [2] - Jones Healthcare and Technology Innovation Conference on April 9, with a presentation by Jennifer Good [3] - Piper Sandler Spring Biopharma Symposium on April 16-17, featuring Jennifer Good and James Cassella [4] Product Details - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [4] - The safety and efficacy of Haduvio have not yet been evaluated by any regulatory authority [7]