Late-breaker abstract accepted for oral presentation on the
interim analysis of cough in patients with idiopathic pulmonary
fibrosis (IPF) at the upcoming European Respiratory Society
International Congress 2022, Barcelona,
Spain, September 4-6
Late-breaker abstract accepted for oral presentation on topline
data for the treatment of prurigo nodularis (PN) at upcoming
31st European Academy of Dermatology and Venereology
Congress, Milan, Italy,
September 7-10
NEW
HAVEN, Conn., Aug. 24,
2022 /PRNewswire/ -- Trevi Therapeutics, Inc.
(Nasdaq: TRVI), a clinical-stage biopharmaceutical company
developing an investigational therapy Haduvio™ (oral
nalbuphine ER) for the treatment of prurigo nodularis (PN) and
chronic cough in adults with idiopathic pulmonary fibrosis (IPF),
today announced two late-breaking abstracts were accepted for
presentation at upcoming fall medical conferences. The previously
disclosed positive interim data from CANAL, a phase 2 trial for
chronic cough in IPF, will be presented as an oral late-breaker
abstract presentation at the European Respiratory Society (ERS)
International Congress 2022 in Barcelona,
Spain. The previously disclosed positive topline data from
PRISM, a phase 2b/3 trial in PN, will
be presented as an oral late-breaker abstract presentation at the
31st European Academy of Dermatology and Venereology
(EADV) Congress in Milan,
Italy.
Conference Details
ERS (European
Respiratory Society) International Congress 2022 (September
4-6)
|
Session:
|
What is hot in
interstitial lung diseases
|
Title:
|
An interim analysis of
a phase 2 trial evaluating oral nalbuphine extended release for
treating chronic cough in idiopathic pulmonary fibrosis
|
Location:
|
Barcelona,
Spain
|
Presentation:
|
September 4, 2:50 PM
CET
|
Presenter:
|
Toby Maher, MD,
Professor of Medicine and Director of Interstitial Lung Disease at
Keck School of Medicine, University of Southern
California
|
Registration
Details:
|
https://www.ersnet.org/congress-and-events/congress/
|
31st EADV
(European Academy of Dermatology and Venereology) Congress
(September 7-10)
|
Session:
|
D2T01.3: Late Breaking
News
|
Title:
|
Oral Nalbuphine
Extended-Release Is Effective in Severe Prurigo
Nodularis–Associated Pruritus: Results From a Phase 2b/3,
Double-Blind, Placebo-Controlled Study
|
Location:
|
Milan, Italy
|
Presentation:
|
September 9, 5:00 PM
CEST
|
Presenter:
|
Sonja Ständer, MD,
Professor of Dermatology and Neurodermatology at the University
Hospital Münster
|
Registration
Details:
|
https://eadvcongress2022.org/
|
Trevi Therapeutics announces multiple
late-breaking abstracts accepted for presentation at upcoming
medical conferences
The CANAL (Cough And NALbuphine) trial is 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 interim analysis (N=26) were announced:
- The primary efficacy endpoint demonstrated a 77.3% reduction in
daytime cough frequency from baseline with the use of nalbuphine ER
compared to a 25.7% reduction with placebo, demonstrating a 52%
placebo-adjusted reduction in the geometric mean percent change in
the daytime cough frequency (p<0.0001).
- Expect to report efficacy and safety data on the full set of
subjects in the third quarter of 2022.
The PRISM (Pruritus Relief through
Itch-Scratch Modulation) trial is a Phase
2b/3 randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of
nalbuphine ER in prurigo nodularis. As previously announced in the
PRISM trial, results comparing subjects randomized to nalbuphine ER
(n=168) or placebo (n=176) achieved the primary and all key
secondary endpoints:
- 25% of nalbuphine ER subjects evaluated at week 14 met the
primary endpoint of a 4-point reduction in the Worst Itch Numerical
Rating Scale from baseline compared to 14% of placebo subjects
(p=0.0157).
- Nalbuphine ER subjects experienced significantly greater
improvements in ItchyQoL vs. placebo (p=0.0002) at week 14, which
was statistically significant across each of the three domains
(symptoms, functional limitations, and emotions). ItchyQoL is used
to measure how pruritus impacts a subject's quality of life.
- 55% of nalbuphine ER subjects had at least a 1-category
improvement in the 5-point scale in their Prurigo Activity Score
(PAS) (pruriginous lesions with excoriations), vs. 38% on placebo
(p=0.006) as evaluated at week 14.
- Nalbuphine ER subjects experienced significantly greater
improvements in the PROMIS sleep disturbance short form 8a vs.
placebo (p=0.0002) at week 14. The first assessment of PROMIS was
made at week 6 of the trial and results at week 6 also demonstrated
a statistically significant improvement.
The safety results of both trials were generally consistent with
the known safety profile of nalbuphine ER from previous trials.
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 130,000 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, it can 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 Prurigo Nodularis
Prurigo nodularis is a chronic disease characterized by severe
pruritus and the presence of nodules, lesions, and excoriations.
Chronic pruritus is a key contributing cause of prurigo nodularis
and manifests in an itch-scratch cycle, which is difficult to
disrupt. There are no approved therapies for prurigo nodularis
where a large unmet need exists due to its impact on patients'
quality of life, function, and emotional well-being.
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 prurigo nodularis and chronic cough in adults with
idiopathic pulmonary fibrosis. 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
itch, cough 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. 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 the expected
timing of reporting top-line data from the full set of subjects'
data from Trevi's Phase 2 CANAL trial of Haduvio in chronic cough
in adults with IPF; Trevi's business plans and objectives,
including future plans or expectations for Haduvio; 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, including with respect to the timing of reporting
top-line data from the Phase 2 CANAL trial; uncertainties regarding
Trevi's ability to execute on its strategy; the risk that positive
interim or top-line results from a clinical trial may not
necessarily be predictive of the results of the completed trial or
other future or ongoing clinical trials; potential regulatory
developments in the United States and foreign countries;
uncertainties regarding fast track designation and the effect such
status could have on the regulatory review or approval process;
uncertainties inherent in estimating Trevi's cash runway, future
expenses and other financial results, including Trevi's ability to
continue as a going concern, comply with its obligations under its
loan facility and fund future operations; 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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