Trevi Therapeutics Completes Enrollment for Phase 2b CORAL Trial of Haduvio in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough

Topline results continue to be expected in the first half of 2025

NEW HAVEN, Conn., Feb. 25, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF. Topline results continue to be expected in the first half of 2025.

"The completion of enrollment in the Phase 2b CORAL trial is a significant milestone in the development of Haduvio for patients with idiopathic pulmonary fibrosis suffering from chronic cough," said James Cassella, Chief Development Officer of Trevi Therapeutics. "Chronic cough has a significant impact on IPF patients, and its persistent physical effects may worsen a patient's overall health. Current off-label treatments and antifibrotics are often ineffective against chronic cough, leaving a substantial unmet need. The results from this study will help us determine the optimal doses of Haduvio to move into our pivotal Phase 3 program. We look forward to reporting topline data in the first half of this year."

Phase 2b IPF Chronic Cough Trial Design (CORAL):
The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) compared to placebo in IPF patients with chronic cough over a 6-week period. Approximately 160 IPF patients with chronic cough were randomized 1:1:1:1 to one of three Haduvio doses 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 is the relative change in 24-hour cough frequency at the end of Week 6 versus baseline for Haduvio compared to placebo, as measured with an objective cough monitor. The trial will also explore secondary endpoints, including patient reported outcome measures for cough.

About Idiopathic Pulmonary Fibrosis Chronic Cough
Chronic cough is highly prevalent in IPF patients, impacting up to 85% of the IPF population. There are ~140,000 U.S. IPF patients and 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 worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in patients with IPF and current off-label treatment options provide minimal benefit to patients. 

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) and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. 

Refractory chronic cough affects approximately 2-3 million adults in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is a highly disruptive disease and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. There are also no approved therapies for RCC in the U.S. 

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.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's expectation of reporting topline data from Trevi's Phase 2b CORAL trial in the first half of 2025. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties regarding the success and timing of Trevi's product candidate development activities, including its ongoing clinical trials, uncertainties regarding Trevi's ability to execute on its strategy, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
[email protected]

Media Contact
Rosalia Scampoli
914-815-1465
[email protected] 

SOURCE Trevi Therapeutics, Inc.