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]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of $10.4 million, an improvement from a net loss of $10.9 million in Q1 2024 [12] - R&D expenses decreased to $7.8 million from $8.8 million in the same quarter of 2024, primarily due to reduced costs related to a human abuse potential study [12] - G&A expenses increased to $3.7 million from $3.1 million in Q1 2024, mainly due to higher personnel-related expenses [13] - As of March 31, 2025, cash and investments totaled $103.3 million, providing a runway into Q4 2026 [13] Business Line Data and Key Metrics Changes - The Phase 2a RIVER trial in refractory chronic cough (RCC) patients showed a 57% placebo-adjusted reduction in cough frequency, achieving a p-value of less than 0.0001 [6] - The Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF) patients completed enrollment with approximately 160 patients across 10 countries [7] Market Data and Key Metrics Changes - RCC affects approximately 2 to 3 million patients in the U.S. with no approved therapies currently available [4] - The company is preparing for the release of top-line data from the CORAL trial this quarter, which is expected to provide insights into treatment options for IPF patients [8] Company Strategy and Development Direction - The company aims to advance its development programs based on the data from the ongoing trials, particularly focusing on chronic cough conditions in both RCC and IPF [8] - There is an emphasis on the importance of the central mechanism underlying neurogenic chronic cough conditions, which differentiates the company's approach from others in the market [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's responsiveness and guidance, which is critical for the development programs [9] - The company plans to be active at the upcoming ATS conference, sharing insights from the RCC data set and engaging with key opinion leaders [10] Other Important Information - The company has received positive feedback from the FDA regarding a Type C request, which is crucial for the development of their programs [9] - The company is considering strategic partnerships for commercialization in Europe and Japan, depending on the data and timing [68] Q&A Session Summary Question: What would be considered a positive readout for the CORAL trial? - A statistically significant positive trial would be necessary for continued development, with no unusual adverse events expected [17][19] Question: What are the next catalysts for the company following the CORAL readout? - The company plans to outline future catalysts after receiving the IPF data, which will inform their path forward [21] Question: Can you clarify the discontinuation rate powered for the study? - The study was powered for a 30% discontinuation rate, but the actual rate was less than 10% [28] Question: What are the long-term patient safety monitoring protocols? - The company plans to include 52 weeks of safety data in their Phase III program, as advised by the FDA [65] Question: What are the trends observed in the RIVER study regarding patient baseline characteristics? - It is too early to determine specific trends, but the drug showed significant efficacy across a broad patient population [71][72]

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]