Nalbuphine ER resulted in a rapid and marked
reduction in recorded daytime cough among patients suffering from
IPF-related cough
The mean change in 24-hour objective cough
frequency was similar in patients with concomitant anti-fibrotic
therapy and without concomitant anti-fibrotic therapy
NEW
HAVEN, Conn., May 22, 2023
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a
clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for difficult
to treat patients with chronic cough in idiopathic pulmonary
fibrosis (IPF), other chronic cough indications, and prurigo
nodularis, today announced the positive results from the Phase 2
CANAL trial in adults with IPF chronic cough has been published in
NEJM Evidence.
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Toby Maher, M.D., Ph.D.,
Professor of Clinical Medicine, Keck School of Medicine,
University of Southern California, and
the national corresponding investigator on the trial, said, "The
publication of these Phase 2 results in NEJM
Evidence demonstrates the potential clinical benefit of
targeting both the central and peripheral mechanisms of chronic
cough with nalbuphine ER for adults with idiopathic pulmonary
fibrosis. Every day in my clinical practice, I see the devastating
impact of chronic cough on the lives of individuals with IPF. This
challenging and debilitating symptom urgently requires effective
treatments. We would like to thank all the investigators, study
staff, and patients who participated in the CANAL trial."
Access publication here:
https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300083
The safety results of the CANAL trial were generally consistent
with the known safety profile of Haduvio from previous trials.
There were two serious adverse events reported during the trial,
neither of which was considered by the investigator to be treatment
related. The most frequently reported treatment emergent adverse
events associated with Haduvio in the CANAL trial were nausea,
fatigue, dizziness, vomiting, constipation, and somnolence.
About IPF
There are estimated to be 140,000 IPF patients in the US and
more than 1 million patients ex-US, with up to 85% of these
patients experiencing chronic cough. There are no approved
therapies for the treatment of chronic cough in IPF, and the cough
is often refractory to antitussive therapy. Patients with chronic
cough in IPF can cough up to 1,500 times per day, leading to
increased feelings of anxiety as it induces breathlessness.
Coughing spells or episodes lead to significant 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.
The chronic cough in IPF may be an early clinical marker of disease
activity, identify patients at high risk of progression, predict
time to death or lung transplant, and may also contribute to
enhanced activation of profibrotic mechanisms and disease worsening
in IPF.
About the CANAL Trial
The Phase
2 Cough And NALbuphine (CANAL)
trial was a double-blind, randomized, placebo-controlled,
2-treatment, 2-period crossover efficacy and safety study of
nalbuphine ER for chronic cough in patients with IPF that was
conducted in the United Kingdom. The study consisted of 2
treatment periods of 3 weeks, with a washout period of 2 weeks
after each treatment period. The primary efficacy endpoint
evaluated the effect of nalbuphine ER tablets on the mean daytime
cough frequency at day 22 compared to placebo as measured by an
objective cough monitor. More information about the CANAL trial is
available at www.clinicaltrials.gov: NCT04030026
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing the investigational therapy Haduvio™ (oral
nalbuphine ER) for difficult to treat patients with chronic cough
in idiopathic pulmonary fibrosis (IPF), other chronic cough
indications, and prurigo nodularis. Haduvio is a dual ĸ-opioid
receptor agonist and µ-opioid receptor antagonist that works both
centrally as well as peripherally in the lungs and has the
potential for a synergistic anti-tussive 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. There are no approved therapies for the treatment of chronic
cough in IPF and current treatment options provide minimal relief
to patients. In IPF, chronic cough may lead to worsening fibrosis
and may be associated with a higher risk of progression, death, or
need for lung transplant.
Parenteral nalbuphine is not scheduled by the US DEA. Trevi
intends to propose Haduvio as the trade name for nalbuphine ER. Its
safety and efficacy have not been evaluated by any regulatory
authority.
For more information, visit www.TreviTherapeutics.com and
follow the Company on 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
future clinical trials, 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 ongoing and planned clinical trials; the risk that
positive data from a clinical trial may not necessarily be
predictive of the results of future 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; as well as other risks
and uncertainties set forth in the quarterly report on Form 10-Q
for the quarter ended March 31, 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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