Expect to enroll approximately 160 subjects
and study 3 doses of Haduvio against placebo
Primary efficacy endpoint is the relative
change in 24-hour cough frequency of Haduvio versus placebo
NEW
HAVEN, Conn., Dec. 5, 2023
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a
clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for patients
with chronic cough in idiopathic pulmonary fibrosis (IPF),
refractory chronic cough (RCC), and prurigo nodularis, today
announced the initiation of its Phase 2b CORAL clinical trial evaluating three doses of
Haduvio against placebo in approximately 160 IPF patients with
chronic cough. This Phase 2b trial
builds on the positive results from the Phase 2a CANAL trial, which
demonstrated a statistically significant reduction in daytime cough
frequency by 75.1%, a 52.5% difference from placebo
(p<0.0001).
After Haduvio reduces daytime IPF chronic
cough by 75.1% in Phase 2a trial, Trevi initiates Phase
2b trial
"We are thrilled to continue our development of Haduvio in IPF
chronic cough patients building on the positive results from our
Phase 2a CANAL trial," said David
Clark, Chief Medical Officer of Trevi Therapeutics. "Chronic
cough impacts up to 85% of IPF patients and is often one of the
first signs of the disease. There are currently no approved
therapies for chronic cough in IPF and it persists despite
antifibrotic treatment. This cough is often reported by patients as
one of the most bothersome aspects of IPF. Haduvio has the
potential to reduce cough and improve quality of life through its
novel mechanism of action, which affects both central brain and
peripheral lung targets."
Phase 2b Trial Design:
COugh Reduction in IPF with nALbuphine ER
(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) against placebo in IPF
patients with chronic cough. Approximately 160 IPF patients with
chronic cough are expected to be randomized 1:1:1:1 to one of three
Haduvio doses or placebo for a period of 6 weeks, which includes an
initial 2-week titration to the target dose followed by 4 weeks of
fixed dose administration.
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 via an
objective cough monitor. The trial will also explore secondary
endpoints, including patient reported outcome measures for cough,
dyspnea, and quality of life.
The protocol for the CORAL trial provides for a sample size
re-estimation (SSRE) analysis once approximately 50% of the
patients in the trial are evaluable for the primary endpoint. The
SSRE is expected to occur in the second half of 2024, and topline
data from the full trial are expected to be available in the first
half of 2025 assuming there are no adjustments made to the sample
size.
About Idiopathic Pulmonary Fibrosis (IPF) Chronic
Cough
There are estimated to be 140,000 IPF patients in the US and
more than 1 million patients ex-US. Up to 85% of these patients
experience a chronic cough.
Patients with chronic cough in IPF can cough up to 1,500 times
per day, leading to increased feelings of anxiety, fatigue, air
hunger, and peripheral oxygen desaturation. The social impact of
chronic cough in IPF further compounds limited exercise ability,
reduced walking distance, and the need to use supplemental oxygen.
In addition to the immediate impact on patients, chronic cough in
IPF may be an early clinical marker of disease activity and
patients at high risk of progression. It may also help predict time
to death or lung transplant and contribute to enhanced activation
of profibrotic mechanisms and disease worsening in IPF.
There are no approved therapies for the treatment of chronic
cough in IPF.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing the investigational therapy Haduvio™ (oral
nalbuphine ER) for patients with chronic cough in idiopathic
pulmonary fibrosis (IPF), refractory chronic cough (RCC), and
prurigo nodularis. Haduvio is a dual ĸ-opioid receptor agonist and
µ-opioid receptor antagonist that works both centrally in the brain
as well as peripherally in the lungs and has the potential for a
synergistic antitussive effect to treat chronic cough.
The impact of chronic cough is significant and often leads to a
decline in patients' social, physical, and psychological quality of
life. In IPF, chronic cough may lead to worsening disease and may
be associated with a higher risk of progression, death, or need for
lung transplant. There are no approved therapies for the
treatment of chronic cough in IPF and current treatment options
provide minimal relief to patients. RCC affects up to 10% of the
adult population and Haduvio's expansion into RCC has the
potential to reach patients suffering from moderate to severe
chronic cough. There are also no approved therapies for RCC in the
US.
Parenteral nalbuphine is not scheduled by the U.S. Drug
Enforcement Agency. 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 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 and planned clinical trials; the risk that
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, including Trevi's
ability to submit and get clearance of an IND and other regulatory
filings on a timely basis; 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 quarterly report on Form 10-Q for the quarter ended
September 30, 2023 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
McManus
Trevi Therapeutics, Inc.
203-304-2499
k.mcmanus@trevitherapeutics.com
Media Contact
Rosalia
Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.