Last patient completed the Phase 2a RIVER
trial in refractory chronic cough (RCC) in early January and
topline results continue to be expected in the first quarter of
2025
Approximately 80% of enrollment complete in
the Phase 2b CORAL trial in
idiopathic pulmonary fibrosis (IPF) patients with chronic cough and
topline results continue to be expected in the first half of
2025
NEW
HAVEN, Conn., Jan. 8, 2025
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI),
a clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine ER) for the
treatment of patients with chronic cough in idiopathic pulmonary
fibrosis (IPF) and refractory chronic cough (RCC), today announced
business updates ahead of its participation in the 14th
Annual LifeSci Partners Corporate Access Event taking place in
San Francisco, CA, from
January 13-15, 2025. This event takes
place during the week of the annual J.P. Morgan Healthcare
Conference.
"We look forward to important readouts on our IPF chronic cough
and RCC trials in the first half of the year, which follow our
strong execution in 2024," said Jennifer
Good, President and CEO of Trevi Therapeutics. "We ended
last year with positive outcomes in both the sample size
re-estimation (SSRE) analysis of the Phase 2b CORAL trial in IPF patients with chronic cough
and in our Human Abuse Potential study. These trials were key
milestones for our IPF clinical trial and overall development
program. This clinical development progress brings us closer to
potentially providing a differentiated therapy to patients who
suffer from chronic cough and have no approved therapies available
to them in the U.S."
Key Company Highlights
- The last patient completed their final visit in the Phase 2a
RIVER trial in RCC, which was designed to enroll approximately 60
patients, at the beginning of January
2025. Topline results for the trial continue to be expected
in the first quarter of 2025.
- The positive outcome for the sample size re-estimation analysis
for the Phase 2b CORAL trial in IPF
patients with chronic cough was announced in December 2024, reaffirming the original sample
size for the trial (N=160). The trial is now approximately 80%
enrolled and topline results continue to be expected in the first
half of 2025.
- The Company estimates its cash, cash equivalents, and
marketable securities were $107.6
million as of December 31,
2024, providing an expected cash runway into the second half
of 2026.
The Company's estimate of its cash, cash equivalents, and
marketable securities as of December 31,
2024, included in this press release is a preliminary
estimate based on information available as of January 8, 2025, and its actual cash, cash
equivalents, and marketable securities may be different from this
preliminary estimate. In addition, the Company's independent
registered public accounting firm has not audited or reviewed this
preliminary estimate.
About Trevi Therapeutics, Inc.
Trevi Therapeutics,
Inc. is a clinical-stage biopharmaceutical company developing the
investigational therapy Haduvio™ (oral nalbuphine extended-release)
for the treatment of chronic cough in patients with 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 currently scheduled by the U.S.
Drug Enforcement Agency.
Chronic cough is a highly prevalent disease in IPF patients,
impacting up to 85% of the IPF population. There are ~140,000 U.S.
IPF patients and the impact of chronic cough is significant with
patients coughing up to 1,500 times per day. This consistent cough
and associated damage may lead to worsening disease, a higher risk
of progression, death, or need for lung transplant. Chronic cough
also 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 off-label
treatment options provide minimal benefit to patients.
Refractory chronic cough affects approximately 2-3 million
adults 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. Haduvio is being developed for
the treatment of moderate to severe RCC. 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 clinical data, and statements regarding Trevi's
expected cash runway 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 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 Trevi's quarterly report on
Form 10-Q for the quarter ended September
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
Jonathan
Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia
Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.