Independent Data Monitoring Statistician
reaffirmed current sample size to remain at N=160
The trial has reached 75% of the
targeted enrollment, and topline results
continue to be expected in the first half of 2025
NEW
HAVEN, Conn., Dec. 12,
2024 /PRNewswire/ -- Trevi Therapeutics, Inc.
(Nasdaq: TRVI), a clinical-stage biopharmaceutical company
developing the investigational therapy Haduvio™ (oral nalbuphine
ER) for the treatment of patients with chronic cough in idiopathic
pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today
announced the positive outcome from the planned sample size
re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in IPF patients with chronic
cough, which requires no change to the current sample size for the
trial (N=160). The trial has reached 75% of the targeted
enrollment, and topline results from the full trial continue
to be expected in the first half of 2025.
The SSRE analysis was conducted on the highest dose (108mg twice
daily) in the trial after 50% of the initial targeted trial
enrollment, or 80 patients, completed the six weeks of treatment.
Based on the SSRE analysis, it was recommended that the CORAL trial
should continue as planned to maintain the pre-specified
conditional power of 80% or greater. The other two potential
pre-specified outcomes of the SSRE analysis were an increase in the
sample size or futility.
"We are pleased that the SSRE outcome supports the continued
execution of the CORAL trial with the total number of patients as
originally planned," said Jennifer
Good, President and CEO of Trevi Therapeutics. "This
positive SSRE outcome is reassuring and confirms the key powering
assumptions of the trial design. We believe this is additional
confirmation of the strong efficacy observed in the Phase 2a CANAL
trial in IPF cough and is an important milestone reaffirming our
belief in Haduvio's best-in-class and first-in-class potential for
patients with IPF chronic cough where there are no approved
therapies."
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. Approximately 160 IPF patients
with chronic cough will be randomized 1:1:1:1 to one of three
Haduvio doses or placebo for a period of 6 weeks. This includes 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 (VitaloJAK®). The trial will also
explore secondary endpoints, including patient reported outcome
measures for cough.
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.
Chronic cough is a highly prevalent disease 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 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 IPF and current off-label
treatment options provide minimal benefit to patients.
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 highly disruptive
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. Haduvio is being developed for
the treatment of moderate to severe RCC. 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
business plans and objectives, including future plans or
expectations for Haduvio and plans and timing with respect to
clinical trials and clinical data, 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 ongoing clinical trials; the risk that
positive data from a clinical trial, or from the sample size
re-estimation analysis announced in this press release, 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, as well as other risks and uncertainties
set forth in Trevi's 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
Katie
Barrett
Trevi Therapeutics, Inc.
203-304-2499
k.barrett@trevitherapeutics.com
Media Contact
Rosalia
Scampoli
914-815-1465
rscampoli@marketcompr.com
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