Continued reduction in WI-NRS observed among
participants who remained in the study through 52 weeks of
treatment
Safety data over 52 weeks: treatment was well
tolerated and consistent with 14-week blinded safety data
Preliminary analyses presented at the European
Academy of Dermatology & Venereology (EADV) Congress
2023
NEW
HAVEN, Conn., Oct. 13,
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 52-week
results from its phase 2b/3 PRISM
open-label extension (OLE) study of Haduvio for the treatment of
prurigo nodularis. The data was presented by Professor Elke Weisshaar on October
13th at the European Academy of Dermatology &
Venereology (EADV) Congress 2023 in Berlin, Germany. The slides from the
presentation will be available for 30 days on the Company's
website.
"We are pleased with the results from our preliminary analyses
of our OLE data supporting the safety profile of nalbuphine ER up
to 52 weeks which were presented at EADV today," said Jennifer Good, President and CEO of Trevi
Therapeutics. "The long-term data also supports the continued
effectiveness of Haduvio in reducing itch over 52 weeks for the
participants who remained in the study. We are preparing for an end
of phase 2 meeting with the FDA to discuss next steps in
development for this program."
The phase 2b/3 PRISM
(Pruritus Relief
through Itch-Scratch Modulation)
trial was a randomized, double-blind, placebo-controlled study to
evaluate the efficacy and safety of nalbuphine ER in prurigo
nodularis. Following the completion of the initial 14-week portion
of the trial, subjects were eligible to roll into an additional
38-week open label extension period during which all participants
received Haduvio 162mg twice a day (BID). Post hoc analyses
demonstrated continued reduction in mean WI-NRS for those
participants who remained on Haduvio through 52 weeks.
Adverse Events Reported During 38-Week Open-Label
Period
151 subjects completed the open-label extension,
adding to the safety database for Haduvio. The safety data
were generally consistent with the safety profile of Haduvio
observed in the 14-week portion of PRISM and previous trials of
Haduvio. Adverse events reported with a frequency greater than
5% in the 38-week open-label period included nausea,
dizziness, vomiting, fatigue, and somnolence. Study
discontinuation due to adverse events occurred in 13% of subjects
during the open-label period, and serious adverse events were
reported for 13 subjects, although only 2 of these events were
considered potentially treatment related.
About PRISM
The Phase 2b/3 Pruritus Relief
through Itch Scratch-Modulation (PRISM) trial was a
randomized, double-blind, placebo-controlled study to evaluate the
efficacy and safety of Haduvio in prurigo nodularis. In the trial,
participants were 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
was the proportion of participants 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. Participants that completed week 14 were 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 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.
Parenteral nalbuphine is not scheduled by the US Drug
Enforcement Agency. Trevi intends to propose Haduvio as the trade
name for oral nalbuphine ER. Its safety and efficacy have not been
evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and
follow Trevi 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, 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 June 30, 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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SOURCE Trevi Therapeutics, Inc.