NEW
HAVEN, Conn., Jan. 4, 2024
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a
clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for patients
with chronic cough in idiopathic pulmonary fibrosis (IPF) and
refractory chronic cough (RCC), today announced a preview of
business updates. Management will be attending the 13th
Annual LifeSci Partners Corporate Access Event in San Francisco from January 8-10 and will be available to discuss
updates. This event takes place during the week of the annual J.P.
Morgan Health Care Conference.
Trevi to attend 13th Annual LifeSci
Partners Corporate Access Event and provides business updates
"Our team is very excited about Trevi's outlook for 2024 having
initiated two clinical trials in chronic cough and the Human Abuse
Potential study late in 2023," said Jennifer Good, President and CEO of Trevi
Therapeutics. "We look forward to advancing the development of
Haduvio through both our Phase 2b
CORAL dose ranging trial for chronic cough in IPF and our Phase 2a
RIVER proof-of-concept trial in refractory chronic cough, as well
as completing the Human Abuse Potential study. We believe Haduvio's
ability to work both centrally in the brain and peripherally in the
lungs has the potential for a synergistic antitussive effect
to treat chronic cough that could enable use among patients with
both moderate and severe cough frequencies. We look forward to a
data-rich year as we progress through this next critical stage
of development."
Key Business Updates
- The Phase 2b CORAL trial in IPF
patients with chronic cough has regulatory approval in 8 of the 10
expected countries. The trial includes a sample size re-estimation
(SSRE) which is expected to occur in the second half of 2024 after
approximately 50% of the patients in the trial are evaluable for
the primary endpoint. Full enrollment in the trial is expected this
year and topline results are expected in the first half of 2025,
assuming no adjustments are made to the sample size as a result of
the SSRE.
- The Phase 2a RIVER trial in RCC patients has been initiated and
the first patient was randomized. Topline data from the trial is
expected in the second half of 2024.
- The Human Abuse Potential study is active and dosing is
expected to begin in January 2024,
with topline data expected in the second half of 2024.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing the investigational therapy Haduvio™ (oral
nalbuphine ER) for patients with chronic cough in idiopathic
pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Trevi
also is evaluating Haduvio for prurigo nodularis. Haduvio is a dual
ĸ-opioid receptor agonist and µ-opioid receptor antagonist that
works both centrally in the brain as well as peripherally in the
lungs and has the potential for a synergistic antitussive effect to
treat chronic cough.
The impact of chronic cough is significant and often leads to a
decline in patients' social, physical, and psychological quality of
life. In IPF, chronic cough may lead to worsening disease and may
be associated with a higher risk of progression, death, or need for
lung transplant. There are no approved therapies for the
treatment of chronic cough in IPF and current treatment options
provide minimal relief to patients. RCC affects up to 10% of the
adult population, and Haduvio's expansion into RCC has the
potential to reach patients suffering from moderate to severe
chronic cough. There are also no approved therapies for RCC in the
US.
Parenteral nalbuphine is not scheduled by the U.S. 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 X (formerly 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 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 data from a clinical trial may not necessarily be
predictive of the results of later 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; 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, as well as other risks and
uncertainties set forth in the quarterly report on Form 10-Q for
the quarter ended September 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.