Data from full set of subjects was
statistically significant for the primary efficacy endpoint of
daytime cough frequency reduction (p<0.0001)
Magnitude of daytime and 24hr cough frequency
reduction were consistent
Key secondary endpoints on patient and
clinician reported outcomes were also statistically
significant
A summary of data will be presented during the
Company's Virtual R&D Day on Monday,
September 19, 2022, from 10 AM-11:45
AM ET
NEW
HAVEN, Conn., Sept. 19,
2022 /PRNewswire/ -- Trevi Therapeutics, Inc.
(Nasdaq: TRVI), a clinical-stage biopharmaceutical company
developing an investigational therapy, Haduvio™ (oral
nalbuphine ER), for the treatment of chronic cough in adults with
idiopathic pulmonary fibrosis (IPF) and prurigo nodularis (PN),
today announced positive results from the full set of subjects in
its Phase 2 Cough And NALbuphine (CANAL) trial
of Haduvio for the treatment of chronic cough in IPF. Dr.
William Forbes will present the data
during the Company's Virtual R&D Day today, Monday, September 19th from
10 AM-11:45 AM ET.
Following the statistically significant efficacy results from
the CANAL trial's interim analysis (N=26) conducted in February 2022, the Company concluded enrollment
early in March 2022 and allowed
enrolled subjects to complete the trial. Topline data from the full
set of subjects (N=38) in the Phase 2 CANAL trial was statistically
significant for the trial's primary endpoint and showed a 52.5%
change compared to placebo (p<0.0001), with a 75.1% reduction in
the geometric mean percent change in daytime cough frequency for
Haduvio.
"We are pleased to announce the positive results from the full
set of subjects from the CANAL trial, which are consistent with the
previously announced interim analysis and further demonstrated that
Haduvio has the potential to reduce IPF patients' cough," said
Jennifer Good, President and CEO of
Trevi Therapeutics. "We analyzed the change of 24hr cough frequency
as well as daytime cough frequency and observed consistent
reductions for both measurements. There are no approved therapies
for chronic cough in these patients, and we are excited to continue
our development in this indication and look forward to starting our
next clinical trial for these patients in the first half of 2023.
We would like to thank the CANAL trial participants and
investigators for their contribution to this research as we look to
improve IPF patients' quality of life."
"It is very promising to see such a significant reduction in
chronic cough in IPF patients with nalbuphine ER," said
Peter Dicpinigaitis, MD, Professor
of Medicine at the Albert Einstein College of Medicine, and
Director of the Montefiore Cough Center, in New York. "There is a large unmet need for
chronic cough therapies and I believe there is broad potential to
improve patients' lives with an oral therapy with a central
mechanism of action."
CANAL Primary Efficacy Endpoint
Analysis (N=38):
Full Analysis
Set
|
Daytime cough
frequency at end of treatment period vs. study
baseline
|
Nalbuphine ER
BID
|
-75.1 %
|
Placebo BID
|
-22.6 %
|
Placebo-adjusted
change
|
52.5%
(p<0.0001)
|
Full Analysis Set includes subjects completing at least 1
treatment period.
Additional Efficacy Analyses:
- Haduvio 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).
- In a post-hoc analysis, 97% of Haduvio 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 Haduvio 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) and Cough Severity Numerical Rating Scale
(p=0.0001).
- Based on the Clinical Global Impression of Change rating
measuring clinicians' view of change since the start of the trial,
62% of Haduvio subjects improved vs. baseline compared to 19% of
placebo subjects (p=0.01).
Safety and Tolerability
Results:
The safety results of the 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. Adverse events most commonly observed during the trial
were nausea, fatigue, constipation, dizziness, somnolence,
vomiting, headache, anxiety and depression.
To register for the event please click here.
Virtual R&D Day
Details
The Virtual R&D Day event will feature presentations from
key opinion leaders on the current treatment landscape and unmet
medical need in patients with chronic cough and prurigo nodularis.
Trevi's leadership team will also present data from the CANAL and
PRISM trials and provide an update on the Company's development
plans for Haduvio. A live webcast, including audio, video, and
presentation slides, will be accessible on
https://ir.trevitherapeutics.com/ at the time of the meeting.
Interested parties unable to watch the live webcast will be able to
view and listen to an archived copy of the webcast, including the
slides, which will be available on
https://ir.trevitherapeutics.com/.
About Chronic Cough in Idiopathic
Pulmonary Fibrosis
IPF is a serious, end of life disease where cough is one of the
most significant symptoms. 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 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, peripheral oxygen desaturation and some patients also
experience cough-related urinary incontinence. 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 CANAL
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 which took
place 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 therapy Haduvio for the
treatment of chronic cough in adults with idiopathic pulmonary
fibrosis and prurigo nodularis. These conditions share a common
pathophysiology that is mediated through opioid receptors in the
central and peripheral nervous systems.
Founded in 2011, Trevi Therapeutics is headquartered
in New Haven, CT.
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 known to be critical mediators of
cough and itch. 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. Trevi intends to
propose Haduvio as the trade name for nalbuphine ER. Nalbuphine ER
has been granted Fast Track designation by the FDA for the
treatment of itch in patients with prurigo nodularis. 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/trevi-therapeutics-announces-positive-data-from-full-set-of-subjects-in-phase-2-canal-trial-of-haduvio-in-the-treatment-of-chronic-cough-in-idiopathic-pulmonary-fibrosis-301626616.html
SOURCE Trevi Therapeutics, Inc.