Trevi Therapeutics to Disclose Q2 2025 Financials and Deliver a Corporate Update on August 7, 2025
Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, has announced promising results from its Phase 2b CORAL trial for Haduvio™ (oral nalbuphine extended-release), an investigational therapy for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
The trial, which involved over 150,000 IPF patients in the U.S., demonstrated a statistically significant reduction in 24-hour cough frequency. The highest dose of 108 mg BID showed a reduction of up to 60.2% compared to placebo, which only experienced a 16.9% reduction (p<0.0001). This reduction was observed across all tested dosages, indicating a dose-dependent efficacy.
Haduvio is not limited to IPF patients alone. It is also being developed for patients with non-IPF interstitial lung disease (non-IPF ILD) and refractory chronic cough (RCC), affecting approximately 2-3 million patients in the U.S. who currently have no approved therapies.
These positive results make Haduvio the first and only investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials involving IPF and RCC patients.
Financially, Trevi Therapeutics is in a strong position. The company completed a $115 million underwritten public offering in June 2025 and ended Q2 2025 with about $204 million in cash, providing a runway into 2029 to support late-stage clinical development and pre-commercial preparations.
Looking ahead, Trevi plans to request an End-of-Phase 2 FDA meeting in Q4 2025 and aims to initiate Phase 3 trials in H1 2026 for Haduvio in chronic cough associated with IPF and potentially other indications.
Mechanistically, Haduvio acts as a kappa opioid receptor agonist and mu opioid receptor antagonist (KAMA), targeting the cough reflex arc both centrally and peripherally, which is novel for treating chronic cough.
Trevi Therapeutics will host a conference call and webcast on August 7, 2025, at 4:30 p.m. ET. Interested parties can dial (877) 870 4263 (domestic) or (412) 317 0790 (international) to participate. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.TreviTherapeutics.com.
For media inquiries, please contact Rosalia Scampoli at 914-815-1465 or [email protected]. For investor relations, please contact Jonathan Carlson at (203) 654 3286 or [email protected].
The original content of the press release can be downloaded from this link.
[1] Trevi Therapeutics to Report Second-Quarter 2025 Financial Results and Provide a Corporate Update on August 7, 2025. (2025). Retrieved from https://www.prnewswire.com/news-releases/trevi-therapeutics-to-report-second-quarter-2025-financial-results-and-provide-a-corporate-update-on-august-7-2025-302518709.html
[2] Trevi Therapeutics Reports Positive Top-Line Results from Phase 2b CORAL Trial of Haduvio™ (Oral Nalbuphine ER) in Chronic Cough Associated with Idiopathic Pulmonary Fibrosis (IPF). (2025). Retrieved from https://www.globenewswire.com/news-release/2025/07/28/2484952/0/en/Trevi-Therapeutics-Reports-Positive-Top-Line-Results-from-Phase-2b-CORAL-Trial-of-Haduvio-TM-Oral-Nalbuphine-ER-in-Chronic-Cough-Associated-with-Idiopathic-Pulmonary-Fibrosis-IPF.html
[3] Haduvio™ (Oral Nalbuphine ER) Demonstrates Statistically Significant Reduction in Cough Frequency in Clinical Trials of Patients with IPF Chronic Cough and Refractory Chronic Cough (RCC). (2025). Retrieved from https://www.globenewswire.com/news-release/2025/07/28/2484953/0/en/Haduvio-TM-Oral-Nalbuphine-ER-Demonstrates-Statistically-Significant-Reduction-in-Cough-Frequency-in-Clinical-Trials-of-Patients-with-IPF-Chronic-Cough-and-Refractory-Chronic-Cough-RCC.html
[4] Trevi Therapeutics' Haduvio™ (Oral Nalbuphine ER) Shows Strong Positive Results in its Phase 2b CORAL Trial for Treating Chronic Cough in IPF Patients. (2025). Retrieved from https://www.globenewswire.com/news-release/2025/07/28/2484948/0/en/Trevi-Therapeutics-Haduvio-TM-Oral-Nalbuphine-ER-Shows-Strong-Positive-Results-in-its-Phase-2b-CORAL-Trial-for-Treating-Chronic-Cough-in-IPF-Patients.html
[5] Trevi Therapeutics Completes $115 Million Underwritten Public Offering. (2025). Retrieved from https://www.globenewswire.com/news-release/2025/07/06/2480733/0/en/Trevi-Therapeutics-Completes-115-Million-Underwritten-Public-Offering.html
The promising results from Trevi Therapeutics' Phase 2b CORAL trial for Haduvio™ suggest potential advancements in health-and-wellness and medical-conditions, specifically for IPF patients with chronic cough. This novel investigational therapy, acting as a kappa opioid receptor agonist and mu opioid receptor antagonist (KAMA), could markedly impact the business and finance landscape, as Trevi Therapeutics is in a financially robust position following a successful $115 million underwritten public offering. Investors and media are invited to attend a conference call and webcast for further information.
