Trevi Therapeutics Announces Oral Presentation and Abstracts at CHEST 2025 Annual Meeting
MWN-AI** Summary
Trevi Therapeutics, Inc. (Nasdaq: TRVI), a biopharmaceutical company focused on developing oral nalbuphine extended-release (ER) for chronic cough, has announced significant presentations scheduled for the CHEST 2025 Annual Meeting from October 19 to 22 in Chicago, Illinois. Professor Philip Molyneaux will deliver an oral presentation detailing the efficacy and safety results from the Phase 2b CORAL trial, which assessed nalbuphine ER in patients suffering from chronic cough due to idiopathic pulmonary fibrosis (IPF). Concurrently, Associate Professor Imran Satia will present key patient-reported outcomes from the earlier Phase 2a RIVER trial focusing on refractory chronic cough (RCC).
The CORAL trial, a randomized, placebo-controlled study, evaluated three different doses of nalbuphine ER for efficacy in reducing cough frequency in IPF patients. The trial aimed primarily to measure changes in 24-hour cough frequency, utilizing an objective cough monitor to assess results. Meanwhile, the RIVER trial was designed to explore the safety and tolerability of nalbuphine in RCC patients, collecting comparable data over two treatment periods separated by washout phases.
Trevi's investigational therapy Haduvio™ represents a potential breakthrough for the estimated 150,000 U.S. patients suffering from IPF chronic cough, as well as the approximately 2-3 million individuals with RCC, many of whom lack approved treatment options. With nalbuphine ER acting on central and peripheral cough receptors, the therapy could significantly improve the quality of life for patients plagued by these debilitating conditions. The upcoming presentations at CHEST 2025 could advance the understanding and acceptance of Haduvio within the medical community, outlining its promise as a new treatment modality for chronic cough.
MWN-AI** Analysis
Trevi Therapeutics, Inc. (Nasdaq: TRVI) recently announced the acceptance of two significant presentations at the CHEST 2025 Annual Meeting, focusing on their investigational therapy, oral nalbuphine ER. This comes at a crucial juncture for the company, as the Phase 2b CORAL trial results, highlighting the efficacy and safety of nalbuphine ER in treating chronic cough associated with idiopathic pulmonary fibrosis (IPF), will be presented orally. Additionally, patient-reported outcomes from the Phase 2a RIVER trial will also be showcased, further validating the importance of the drug in managing refractory chronic cough (RCC).
With approximately 150,000 patients with IPF in the U.S. suffering from uncontrolled chronic cough and no FDA-approved treatments currently available, Trevi’s findings could potentially fulfill a significant unmet medical need. The attention garnered from these presentations could enhance investor confidence, leading to increased interest in the stock.
Investors should note that Trevi’s unique positioning in the market—targeting both IPF and RCC—coupled with its promising trial outcomes, positions it well for potential strategic partnerships and collaborations, which could augment the company's financial stability.
However, caution is warranted as the market typically reacts to clinical trial outcomes. Investors should closely monitor the reception of these presentations and any subsequent investor call or announcement from Trevi. Should the results affirm the anticipated efficacy of nalbuphine ER, especially against placebo, the stock may see a significant uptick.
For now, watching Trevi Therapeutics' performance at CHEST 2025 and subsequent market reactions may offer valuable insights into its potential growth trajectory. It’s advisable to keep an eye on news updates, as they could influence trading strategies and investment decisions moving forward.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
Professor Philip Molyneaux will give an oral presentation on the key efficacy and safety results from the Phase 2b CORAL trial of nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF)
Associate Professor Imran Satia will give a poster presentation on the patient-reported outcomes from the Phase 2a RIVER trial of nalbuphine ER for the treatment of patients with refractory chronic cough (RCC)
NEW HAVEN, Conn. , Oct. 8, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy oral nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced the acceptance of two abstracts for presentation at the CHEST 2025 Annual Meeting , to be held from October 19 to 22 in Chicago, Illinois . The key safety and efficacy results from the Phase 2b CORAL dose-ranging trial of nalbuphine ER for the treatment of chronic cough in patients with IPF was accepted for oral presentation. Additionally, patient-reported outcome results from the Phase 2a RIVER proof-of-concept trial of nalbuphine ER for the treatment of patients with RCC will be featured as a poster presentation.
Abstract: A randomized, placebo-controlled, parallel-group phase 2b trial of nalbuphine extended-release for chronic cough in patients with idiopathic pulmonary fibrosis
Oral Presentation Session: Pulmonary Fibrosis: Advances in Pharmacotherapy Late-Breaking Scientific Abstracts
Session Date & Time: October 21 , 1:45-2:30pm CDT
Location: Exhibit Hall Rapid Fire Area 4B
Oral Presenter: Philip Molyneaux, MD, PhD
Abstract: Patient-reported outcomes from a phase 2a trial of extended-release nalbuphine for patients with refractory chronic cough
Poster Session: Late-Breaking Scientific Abstracts Posters: Guidelines, Diffuse Lung Disease, Pulm Vasc Disease and More
Session Date & Time: October 21 , 1:45-2:30pm CDT
Location: Exhibit Hall Poster Area 6
Poster Presenter: Imran Satia, MB, BChir, PhD, MRCP
About the Phase 2b CORAL Trial
The Phase 2b Cough Reduction in IPF with Nalbuphine ER ( CORAL ) trial was a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg twice daily (BID)) compared to placebo for the treatment of chronic cough in patients with IPF over a 6-week treatment period. 165 patients with IPF chronic cough were randomized 1:1:1:1 to one of three nalbuphine ER dose groups or placebo with an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial was the relative change in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for the modified intent-to-treat (mITT) population at the end of Week 6 versus Baseline for nalbuphine ER compared to placebo. The mITT population consisted of all patients who were randomized and received at least one dose of study drug or placebo.
About the Phase 2a RIVER Trial
The Phase 2a Refractory Chronic Cough Improvement Via Nalbuphine ER ( RIVER ) trial was a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, and tolerability of nalbuphine ER for the treatment of patients with RCC. Each treatment period lasted 21 days, separated by a 21-day washout period. During the nalbuphine ER treatment period, patients were titrated with assessments at 27 mg BID, 54 mg BID, and 108 mg BID for objective cough and other assessments at each dose. The primary endpoint of the trial was the mean change in 24-hour cough frequency, as determined by an objective cough monitor, for the full analysis set (FAS) population at Day 21. The FAS population included all patients who received at least one dose of study drug and have objective cough count data on both Baseline and Day 21 in at least one treatment period.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials of patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.
Chronic cough in patients with IPF and non-IPF ILD is a condition with a high unmet need and no FDA-approved therapies. There are ~150,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life.
Refractory chronic cough is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8?weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially.
Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn .
Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
SOURCE Trevi Therapeutics, Inc.
FAQ**
What were the key efficacy results from the Phase 2b CORAL trial of nalbuphine ER presented by Professor Philip Molyneaux at CHEST 2025, and how do they compare to existing treatments for chronic cough in patients with idiopathic pulmonary fibrosis, Trevi Therapeutics Inc. TRVI?
Can you elaborate on the patient-reported outcomes from the Phase RIVER trial of nalbuphine ER for refractory chronic cough that Associate Professor Imran Satia is presenting at CHEST 2025, and their implications for Trevi Therapeutics Inc. TRVI's future strategies?
How does Trevi Therapeutics Inc. TRVI plan to address the high unmet need for chronic cough treatments highlighted by the significant number of patients suffering from this condition, especially those with idiopathic pulmonary fibrosis and refractory chronic cough?
What feedback or insights does Trevi Therapeutics Inc. TRVI hope to gain from the presentations at the CHEST 2025 Annual Meeting, and how might this inform their ongoing clinical development and regulatory strategy for nalbuphine ER?
**MWN-AI FAQ is based on asking OpenAI questions about Trevi Therapeutics Inc. (NASDAQ: TRVI).
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