Completed enrollment and last patient last visit in the Phase 2b CORAL trial in IPF patients with chronic cough; topline results continue to be expected in the second quarter of 2025
Announced positive topline results from the Phase 2a RIVER trial in patients with refractory chronic cough
Management to host a conference call and webcast today at 4:30 p.m. ET
NEW HAVEN, Conn., May 8, 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 in patients with refractory chronic cough (RCC), today announced financial results for the quarter ended March 31, 2025, and provided business updates.
"The RIVER data in patients with RCC demonstrated the clinical significance of Haduvio's centrally and peripherally acting mechanism and its potential across a broad range of chronic cough patients and cough counts," said Jennifer Good, President and CEO of Trevi Therapeutics. "Building on that positive momentum, we look forward to the topline results from the Phase 2b CORAL trial expected this quarter for the treatment of IPF patients with chronic cough. Chronic cough is a significant burden to IPF patients and there are no approved therapies. Trevi is at a pivotal moment with promising data, a dedicated development team advancing trials, and a strong balance sheet to support the continued development of Haduvio."
First Quarter 2025 Financial Results and Recent Business Highlights
- Enrollment was completed in February 2025 in the Phase 2b CORAL trial of Haduvio in chronic cough patients with IPF and the last patient last visit was completed in April 2025. Topline results for the CORAL trial remain on track for the second quarter of 2025.
- In March, Trevi announced positive topline results from its Phase 2a RIVER trial of Haduvio in patients with RCC (N=66). Haduvio met the primary endpoint with a statistically significant reduction in objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) and includes unexplained chronic cough. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is a highly debilitating 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.
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 business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, expectations regarding Trevi's uses and sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the annual report on Form 10-K for the year ended December 31, 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.
Trevi Therapeutics, Inc.
Selected Balance Sheet Data
(unaudited)
(amounts in thousands)
March 31,2025
December 31,2024
Cash and cash equivalents
$
19,374
$
34,097
Marketable securities
83,883
73,525
Working capital
98,755
98,919
Total assets
107,004
110,900
Stockholders' equity
99,457
99,644
Trevi Therapeutics, Inc.
Selected Statement of Operations Data
(unaudited)
(amounts in thousands, except per share amounts)
Three Months EndedMarch 31,
2025
2024
Operating expenses:
Research and development
$
7,811
$
8,804
General and administrative
3,659
3,102
Total operating expenses
11,470
11,906
Loss from operations
(11,470)
(11,906)
Other income, net
1,119
996
Loss before income taxes
(10,351)
(10,910)
Income tax benefit
11
8
Net loss
$
(10,340)
$
(10,902)
Basic and diluted net loss per common share outstanding
$
(0.09)
$
(0.11)
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted
117,610,750
99,517,212
Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 carlsonj@trevitherapeutics.com
Media Contact Rosalia Scampoli 914-815-1465 rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.