Topline results are expected in the first
quarter of 2025
NEW
HAVEN, Conn., Oct. 21,
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 announced
that it has completed enrollment in its Phase 2a trial for the
treatment of RCC ("RIVER") and expects to report topline data in
the first quarter of 2025.
"We are happy to have completed enrollment for our Phase 2a
RIVER trial for the treatment of RCC," said Jennifer Good, President and CEO of Trevi
Therapeutics. "RCC impacts approximately 2-3 million adults in the
U.S. and with no approved treatment options, there is a large unmet
need for new therapies that address cough hypersensitivity. We look
forward to reporting the topline results for RIVER early next year
and building on the positive results we have seen in studying
chronic cough in IPF."
Phase 2a Trial Design: Refractory Chronic Cough Improvement
Via Nal ER (RIVER)
The Phase 2a RIVER trial is a randomized, double-blind,
placebo-controlled, two-treatment, two-period, crossover study
designed to evaluate the efficacy, safety, tolerability and dosing
of Haduvio for the treatment of RCC. The trial is being conducted
at multiple sites in the United
Kingdom and Canada. The
primary endpoint of the trial is a mean change in 24-hour cough
frequency in the overall population as determined using an
objective cough monitor. Based on the screening results, the study
will enroll patients into one of two subgroups: 10-19 coughs/hour
(moderate 24-hour cough frequency) and ≥20 coughs/hour (high
24-hour cough frequency). The trial will also explore secondary
endpoints, including patient-reported outcome measures for cough
frequency and severity. The trial was designed to enroll
approximately 60 adult patients.
About Refractory Chronic Cough (RCC)
Refractory chronic cough has no approved therapies in the U.S. and
is defined as a persistent cough lasting >8 weeks despite
treatment for an underlying condition (i.e., asthma,
gastroesophageal reflux disease, non-asthmatic eosinophilic
bronchitis, and upper airway cough syndrome or post-nasal drip) or
where no underlying condition exists. RCC affects ~2-3 million
patients in the U.S. and is caused by cough reflex hypersensitivity
in both 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 burdens
for patients and those around them.
About Trevi Therapeutics, Inc.
Trevi Therapeutics,
Inc. is a clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine extended-release
(ER)) for the treatment of chronic cough in idiopathic pulmonary
fibrosis (IPF) and refractory chronic cough (RCC). Haduvio acts on
the cough reflex arc both centrally and peripherally as a kappa
agonist and a mu antagonist (KAMA), which are opioid receptors that
play a key role in controlling cough hypersensitivity. 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
expectation of reporting topline data from Trevi's Phase 2a RIVER
trial in the first quarter of 2025. 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, uncertainties regarding Trevi's ability to execute on its
strategy, 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.