Expect to enroll 60 subjects across a broad
range of cough frequencies
RIVER topline data expected in the second half
of 2024
NEW
HAVEN, Conn., Nov. 2, 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), refractory chronic cough (RCC), and prurigo
nodularis, today announced the initiation of its Phase 2a
RIVER clinical trial evaluating Haduvio in RCC patients. RCC
affects up to 10% of adults worldwide and is defined by a cough
that lasts >8 weeks and does not respond to therapy for an
underlying condition. Topline data from the RIVER trial is expected
in the second half of 2024.
"We are excited about the initiation of the RIVER study in
refractory chronic cough," said Jennifer
Good, President and CEO of Trevi Therapeutics. "Based on our
positive data in IPF chronic cough, we believe Haduvio has the
potential to provide therapy for severe cough across a broad range
of cough frequencies through its differentiated central and
peripheral mechanism of action. The RIVER study will not only
enroll severe RCC subjects in the high cough frequency population,
but also subjects with a moderate cough frequency, where a
significant unmet need still exists."
Phase 2a Trial Design: Refractory Chronic Cough
Improvement Via Nal ER (RIVER)
The RIVER trial is a double-blind, randomized, placebo-controlled,
2-period crossover study evaluating the safety and efficacy of
Haduvio in reducing chronic cough in RCC subjects. Approximately 60
RCC subjects are expected to be randomized with a 1:1
stratification between those with 10-19 coughs/hour (moderate
24-hour cough frequency) and those with ≥20 coughs/hour (high
24-hour cough frequency). Each treatment period will last 21 days,
separated by a 21-day washout period, and subjects on Haduvio will
have the dose titrated from 27 mg once a day (QD) up to 108 mg
twice a day (BID) across the 21-day dosing period.
The primary efficacy endpoint for the trial is the relative
change in 24-hour cough frequency at Day 21 from treatment period
baseline for Haduvio compared to placebo, as measured via an
objective cough monitor. The study will also explore secondary
endpoints, including patient reported outcome measures for cough
and dyspnea.
About Refractory Chronic Cough (RCC)
Refractory
chronic cough affects up to 10% of the adult population and is
defined as a persistent cough lasting >8 weeks, despite
treatment for an underlying condition. RCC is caused by cough
reflex hypersensitivity in the central and peripheral
nerves. It is highly disruptive and accompanied by a wide
range of complications, ranging from urinary incontinence in
females to sleep disruption and social embarrassment that causes
significant social and economic burden for patients and those
around them.
The most common causes of RCC are asthma, gastroesophageal
reflux disease (GERD), non-asthmatic eosinophilic bronchitis, and
upper airway cough syndrome or post-nasal drip. There are no
approved therapies for RCC in the U.S., E.U., or U.K.
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), refractory chronic cough,
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 and has the potential for a
synergistic anti-tussive 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. There are no approved therapies for the treatment of chronic
cough in IPF and current treatment options provide minimal relief
to patients. 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.
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 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 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.