Haduvio (oral nalbuphine ER) demonstrated
statistically significant results on the primary efficacy endpoint
as measured by a 4-point reduction in the Worst Itch –
Numerical Rating Scale (WI-NRS) (p=0.0157)
The trial also met key secondary endpoints,
with a safety profile consistent with prior studies
Topline data will be presented by management
and study investigator, Jennifer L Parish, MD, on a conference call
and webcast on June 29, 2022, at
8:30 am EDT
NEW
HAVEN, Conn., June 29,
2022 /PRNewswire/ -- Trevi Therapeutics, Inc.
(Nasdaq: TRVI), a clinical-stage biopharmaceutical company
developing an investigational therapy Haduvio™ (oral
nalbuphine ER) for prurigo nodularis and chronic cough in
idiopathic pulmonary fibrosis (IPF), today announced positive
results from its Phase 2b/3
Pruritus Relief through Itch-Scratch
Modulation (PRISM) trial of Haduvio in treating prurigo
nodularis.
Trevi Therapeutics Ph2b/3 PRISM trial of
Haduvio achieves statistical significance for the treatment of
Prurigo Nodularis
"We are very pleased to announce the statistically significant
results for Haduvio from the PRISM trial, the first and only oral
therapy to demonstrate in a clinical trial a positive result in
treating prurigo nodularis," said Jennifer
Good, President and CEO of Trevi Therapeutics. "This
positive trial in prurigo nodularis, along with the highly
statistically significant data from the interim analysis of our
Phase 2 trial in IPF chronic cough that we presented earlier this
year, further supports our belief that Haduvio could potentially
benefit patients across a broad range of refractory chronic
pruritic and cough conditions."
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.
"Prurigo nodularis is one of the most challenging dermatologic
diseases for clinicians to manage," said Jennifer L Parish, MD,
Dermatologist at Parish Dermatology and study investigator for the
PRISM trial. "Patients suffer not only from the itching and the
resulting excoriations, but many also suffer from anxiety often
caused by the lack of effective treatments. It is
exciting to see therapeutic options in development for this
potentially devastating condition."
In the Phase 2b/3 PRISM trial,
results comparing subjects randomized to Haduvio monotherapy
(n=168) or placebo (n=176) showed:
- 25% of Haduvio subjects evaluated at week 14 met the primary
endpoint of a 4-point reduction in WI-NRS from baseline compared to
14% of placebo subjects (p=0.0157).
- Haduvio 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 Haduvio subjects saw at least a 1-category improvement
in the 5-point scale in their Prurigo Activity Scale (PAS)
(pruriginous lesions with excoriations), vs. 38% on placebo
(p=0.006) as evaluated at week 14.
"In this study, Haduvio demonstrated an early onset of effect to
reduce itch, which we believe improved quality of life for the
patient as well as the underlying skin healing," said Dr.
Bill Forbes, Chief Development
Officer at Trevi Therapeutics. "We believe the ability of Haduvio
to work both centrally and peripherally helps to break the
ingrained itch-scratch cycle, which leads to the difficulty in
treating prurigo nodularis. We look forward to analyzing these data
further, along with the open label extension data, to help inform
continued development in this area of high unmet need."
The safety results of the trial were generally consistent with
the known safety profile of Haduvio from previous
trials. During the double-blind titration period (weeks 1-2)
Treatment-Emergent Adverse Events (TEAE) were more common in the
Haduvio-treated subjects (66.1%) vs. placebo-treated subjects
(31.3%). During the 12-week fixed-dose period, the occurrence of
TEAEs were generally similar between Haduvio and placebo groups
(48% Haduvio, 45% placebo). Discontinuations during the 14 weeks of
the trial were 36.9% in Haduvio-treated subjects vs. 19.3% in
placebo-treated subjects. During the 14-week double-blind
portion of the PRISM trial, 8 subjects on Haduvio and 6 subjects on
placebo experienced at least one treatment emergent Serious Adverse
Event (SAE). None of the SAEs were considered by the investigator
to be treatment-related. Adverse events most commonly observed with
Haduvio were nausea, dizziness, headache, and constipation.
Conference Call Details
To participate in the live
conference call by phone, please dial (888) 317 6003 (domestic) or
(412) 317 6061 (international) and provide access code 8601030. A
live audio webcast and presentation will be accessible from the
'Investors & News' section on the Company's website at
www.trevitherapeutics.com. An archived replay of the webcast and
the presentation will also be available for 60 days on the
Company's website following the event.
About PRISM
The Phase 2b/3 Pruritus
Relief through Itch Scratch-Modulation
(PRISM) trial is a randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of Haduvio in prurigo
nodularis. In the trial, subjects are randomized equally across two
treatment groups (oral Haduvio 162 mg or placebo, twice daily
including an initial 2-week blinded titration period). The primary
endpoint of the trial is the proportion of subjects achieving a
greater than or equal to 4-point improvement in the weekly mean
Worst Itch Numerical Rating Scale (WI-NRS) score at Week 14
compared to baseline. Subjects that complete week 14 are eligible
to roll into an additional 38-week open label extension trial. More
information about the PRISM trial is available
at www.clinicaltrials.gov: NCT03497975
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 proposed indication of
reduction of moderate to severe pruritus in adults 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, Trevi's business plans and
objectives, including future plans or expectations for Trevi's
product candidates; 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
our clinical trials and next steps in the development path for
Trevi's product candidates 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 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 March 31, 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.