Trevi Therapeutics(US:TRVI) Prnewswire·2025-11-13 21:05Core 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].