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]

Trevi Therapeutics Inc (TRVI) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to the Trevy Therapeutics First Quarter twenty twenty five Earnings Conference Call. At this time, all participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans and prospects constitut ...

Financial Data and Key Metrics Changes - For Q4 2024, the company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in Q4 2023, indicating a deterioration in financial performance [17] - R&D expenses increased to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, primarily due to higher clinical trial costs [17] - G&A expenses rose to $2.9 million in Q4 2024 from $2.4 million in Q4 2023, mainly due to increased stock-based compensation and personnel-related expenses [17] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $107.6 million, bolstered by a $50 million offering completed in December [18] Business Line Data and Key Metrics Changes - The company achieved three positive data readouts in 2024, including studies related to chronic cough patients with IPF and refractory chronic cough [3][4] - The Human Abuse Potential Study showed statistically significant lower drug liking compared to butorphanol, supporting the drug's profile [6] - The Sample Size Re Estimation analysis confirmed the original sample size of 160 patients for the Phase 2b study in IPF chronic cough, allowing the company to stay on track for enrollment [8] Market Data and Key Metrics Changes - The RIVER trial in patients with refractory chronic cough showed a 57% placebo-adjusted change from baseline with a p-value of less than 0.0001, indicating strong efficacy [11] - The company is targeting a subsegment of the refractory chronic cough population, focusing on patients who have failed prior therapies, which represents a significant unmet need [12] Company Strategy and Development Direction - The company plans to develop HEDUVO in serious chronic cough conditions, positioning it as a first-in-class therapy in IPF and potentially best-in-class across chronic cough indications [15] - The next steps include preparing for an end-of-Phase 2 meeting with the FDA for the IPF program and developing a protocol for the next RCC study [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical trials and the positive data readouts, which are expected to drive future growth [3][4] - The company anticipates cash burn of approximately $12 million to $14 million per quarter in Q1 and Q2 of 2025, with guidance remaining unchanged for cash runway into the second half of 2026 [18][19] Other Important Information - The company plans to present more data at upcoming conferences, including the American Thoracic Society meeting in May and the European Respiratory Society Congress in September [14][15] - The company is actively planning for the next steps in the development of HEDUVO, with a focus on both IPF and RCC [12] Q&A Session Summary Question: Could you speak about the patients enrolled in the CORAL study? - Management confirmed that no changes were made to the study protocol or sites after the sample size estimation, maintaining consistency in the patient population [22][23] Question: Can you comment on the discontinuation rate in the CORAL study? - The discontinuation rate remained in single digits throughout the study, indicating stability in patient retention [24] Question: What are the placebo response expectations for the IPF chronic cough Phase 2 study? - Management indicated that the placebo effect has been well-behaved in prior studies, with conservative assumptions around the expected effect size [29] Question: How will the RCC patient population be split between P2X3 and HEDUVO? - The company plans to target treatment failure patients, suggesting that HEDUVO will be considered after P2X3 therapy fails [33] Question: What secondary endpoints will matter most for driving HEDUVO prescriptions? - Management highlighted the importance of linking secondary endpoints to the primary endpoint of objective cough severity, with quality of life metrics also being considered [80]