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
carlsonj@trevitherapeutics.com
Media Contact
Rosalia
Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.
