Data from full set of subjects was
statistically significant for the primary efficacy endpoint
(p<0.0001)
Key secondary patient and clinician-reported
outcomes supported positive primary endpoint
NEW
HAVEN, Conn., Oct. 27,
2022 /PRNewswire/ -- Trevi Therapeutics, Inc.
(Nasdaq: TRVI), a clinical-stage biopharmaceutical company
developing an investigational therapy Haduvio™ (oral
nalbuphine ER) for the treatment of serious chronic cough
conditions, today announced data from the full set of subjects from
CANAL, a phase 2 trial in idiopathic pulmonary fibrosis (IPF)
chronic cough, will be presented as an oral presentation at the
upcoming British Thoracic Society's (BTS) Winter Meeting 2022
taking place in London, United
Kingdom.
BTS (British Thoracic Society) Winter Meeting 2022
(November 23-25)
Session:
|
Hot shots" – What's hot
in cough?
|
Title:
|
S15 – Efficacy of oral
nalbuphine extended release for the treatment of chronic
cough in idiopathic pulmonary fibrosis: analysis of a phase 2
study
|
Location:
|
QEII Centre, Broad
Sanctuary, Westminster, London, SW1P 3EE
|
Presentation:
|
November 23, 8:45 AM
CET
|
Presenter:
|
Philip Molyneaux, MD,
Faculty of Medicine, National Heart & Lung Institute,
Imperial College London
|
Registration
Details:
|
https://www.brit-thoracic.org.uk/education-and-events/winter-meeting/
|
"IPF places a high burden on patients and caregivers impacting
over a million patients globally. Coughing spells can lead to
significant fatigue, air hunger, and oxygen desaturation with a
negative impact on quality of life for the patient. The results of
the study demonstrate the potential of nalbuphine ER's central and
peripheral mechanism of action to significantly reduce chronic
cough in IPF and potentially improve the quality of life in
afflicted patients," said Prof. Philip
Molyneaux.
The CANAL (Cough And NALbuphine) trial was
a Phase 2 double-blind, randomized, placebo-controlled,
2-treatment, 2-period crossover efficacy and safety study of
nalbuphine ER for chronic cough in IPF. Statistically significant
efficacy results from the full analysis set (N=38) were previously
announced and showed the following:
- Nalbuphine ER subjects had a 76.1% reduction in 24hr cough
frequency compared to a 25.3% of placebo subjects, a 50.8%
placebo-adjusted change (p<0.0001).
- Reduction in 24-hour cough frequency was consistent with the
reduction in daytime cough frequency.
- Key secondary endpoints on patient and clinician-reported
outcomes were also statistically significant.
- In a post-hoc analysis, 97% of nalbuphine ER subjects had at
least a 30% reduction in 24hr cough frequency compared to 35% of
placebo subjects, signifying a clinically meaningful reduction in
cough (p<0.0001).
- Subjects on nalbuphine ER experienced a statistically
significant improvement as measured by their patient-reported
outcomes compared to placebo over the 3-week treatment period in
the EXACT2: Cough Frequency Score (p=0.001).
Safety and Tolerability Results:
The safety results of
the trial were generally consistent with the known safety profile
of nalbuphine ER 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
common adverse events observed during the trial were nausea,
fatigue, constipation, dizziness, somnolence, vomiting, headache,
anxiety and depression.
About Chronic Cough in Idiopathic Pulmonary
Fibrosis
IPF is a serious, end-of-life disease. Chronic
cough is one of the most common symptoms of IPF and has a
significant impact on quality of life in these patients.
There are estimated to be 140,000 IPF patients in the US and
more than 1 million patients ex-US, where up to 85% of these
patients experience chronic cough. There are no approved therapies
for the treatment of chronic cough in IPF and the cough often isn't
affected by antitussive therapy. Patients with chronic cough in IPF
can cough up to 1,500 times per day, leading to increased feelings
of fear and stress as it causes shortness of breath. Coughing
spells or episodes lead to significant fatigue, an urge to breathe,
low levels of oxygen in blood, and some patients also experience
loss of bladder control. The social impact of chronic cough in IPF
is increased because of limited exercise ability, reduced walking
distance, and the need to use additional oxygen. Chronic cough
in IPF may be an early clinical marker of disease activity that
could potentially help to identify patients at high risk of
progression and predict time to death or lung transplant. In
addition, chronic cough in IPF may also contribute to enhanced
activation of profibrotic mechanisms and disease worsening.
About the Ph2 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 was to evaluate 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 focused on the development and commercialization of the
investigational oral therapy Haduvio™
(nalbuphine ER) for the treatment of serious chronic
cough conditions. The Company has successfully completed a Phase 2
trial of Haduvio for the treatment of chronic cough in
adults with idiopathic pulmonary fibrosis (IPF). Based
on this positive data, Trevi plans to focus future
clinical development on chronic cough conditions, including
IPF, refractory chronic cough, and interstitial lung diseases
(ILDs).
For more information, visit www.TreviTherapeutics.com and follow
the company on Twitter and LinkedIn.
About Haduvio
Haduvio, an investigational
therapy, is an oral extended-release (ER) formulation of
nalbuphine. Nalbuphine is a mixed
ĸ-opioid receptor agonist and µ-opioid
receptor antagonist that has been approved and marketed as an
injectable for pain indications for more than 20 years in the
United States and Europe. The ĸ- and
µ-opioid receptors are centrally and peripherally
active and known to be critical mediators of cough, itch, and
certain movement disorders. Nalbuphine's mechanism of
action may also mitigate the risk of abuse associated with
µ-opioid agonists because it antagonizes, or blocks,
µ-opioid receptors. Parenteral nalbuphine
is not currently scheduled as a controlled substance by
the DEA in the United States or by
regulatory authorities in most
of Europe. Trevi intends to
propose Haduvio as the trade name for
nalbuphine ER. Its safety and efficacy have not been
evaluated by any regulatory authority.
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 Trevi's product candidates and plans with respect
to future 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; 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
Trevi's product candidates 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; uncertainties regarding the scope, timing and severity of
the COVID-19 pandemic, the impact of the COVID-19 pandemic on
Trevi's clinical operations and actions taken in response to the
pandemic; as well as other risks and uncertainties set forth in the
quarterly report on Form 10-Q for the quarter ended June 30,
2022 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.