Phase 2b CORAL
trial in idiopathic pulmonary fibrosis (IPF) chronic cough reaches
50% enrollment milestone; sample size re-estimation results
expected in December 2024
Human Abuse Potential (HAP) study dosing
complete; topline results expected in December 2024
NEW
HAVEN, Conn., Oct. 3, 2024
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a
clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for the
treatment of chronic cough in idiopathic pulmonary fibrosis (IPF)
and refractory chronic cough (RCC), today provided updates on its
clinical development programs.
"We are excited to report these important clinical milestones
that mark an impending data-rich period for Trevi's Haduvio," said
Jennifer Good, President and CEO of
Trevi Therapeutics. "Chronic cough in IPF is one of the most
difficult-to-treat cough conditions where antifibrotics have not
shown a benefit. We believe the centrally and peripherally acting
mechanism of Haduvio uniquely positions it to work throughout the
cough reflex arc and potentially offer relief for this important
unmet need in IPF."
Clinical Updates
- The Phase 2b CORAL trial for
the treatment of chronic cough in patients with IPF has enrolled
50% of the targeted study enrollment, which is the number of
patients needed for the pre-specified sample size re-estimation
(SSRE). The SSRE will be performed once the last of these patients
complete the six weeks of treatment. The outcome of the SSRE result
is expected in December 2024. The
three potential SSRE outcomes are: maintain current sample size
(N=160), upsize within a pre-specified range, or evaluate for
futility. Assuming no adjustments are made to the sample size,
topline results are expected in the first half of 2025.
- The Human Abuse Potential (HAP) study completed dosing. Topline
results are expected in December
2024.
- The Phase 2a RIVER trial for the treatment of RCC has
enrolled the planned sample size but remains open to allow for
additional enrollment in both arms to approximate the
stratification targets. Topline results are now expected in the
first quarter of 2025.
About Trevi Therapeutics, Inc.
Trevi
Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing the investigational therapy
Haduvio™ (oral nalbuphine ER) for the treatment
of chronic cough in idiopathic pulmonary fibrosis
(IPF) and refractory chronic cough
(RCC). Haduvio is an extended-release
(ER) 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. Parenteral nalbuphine is not
scheduled by the U.S. Drug Enforcement
Agency.
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 benefit to patients. Chronic cough 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
refractory chronic cough. There are also no approved therapies for
RCC in the U.S.
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 and timing of Trevi's product candidate development
activities, including its ongoing clinical trials; the risk that
positive 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, 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 June 30, 2024 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 Barrett
Trevi Therapeutics,
Inc.
203-304-2499
k.barrett@trevitherapeutics.com
Media Contact
Rosalia
Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.