Initiated Phase 2a RIVER trial of Haduvio in
refractory chronic cough (RCC) patients and expect topline data in
the second half of 2024
Expect to initiate Phase 2b dose-ranging trial of Haduvio for the
treatment of chronic cough in idiopathic pulmonary fibrosis (IPF)
patients in the fourth quarter of 2023
Management to host a conference call and
webcast today at 4:30 p.m. ET
NEW
HAVEN, Conn., Nov. 9,
2023 /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), refractory chronic cough (RCC), and
prurigo nodularis, today announced financial results for the
quarter ended September 30, 2023, as well as provided business
updates.
Haduvio is well-positioned in IPF chronic
cough and RCC based on its ability to target cough centrally and
peripherally
"We are thrilled to have initiated our Phase 2a RIVER trial of
Haduvio in patients with refractory chronic cough, which builds on
the strength of the clinical data seen with Haduvio in IPF chronic
cough," said Jennifer Good,
President and CEO of Trevi Therapeutics. "Refractory chronic cough
impacts up to 10% of the adult population globally. We believe
Haduvio is well-positioned in IPF chronic cough, as well as in RCC,
based on its ability to target cough centrally and peripherally
which potentially supports the ability to work across a wide range
of cough conditions."
Key Business Updates
- Initiated the Phase 2a RIVER trial in patients with refractory
chronic cough and expect topline data in the second half of 2024.
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).
- Expect to initiate the Phase 2b
dose-ranging trial of Haduvio for the treatment of chronic cough in
IPF in the fourth quarter of 2023 and the Phase 1b trial to evaluate the effect of Haduvio on
respiratory physiology in patients with IPF in the first quarter of
2024.
- Secured IV butorphanol supply for the human abuse potential
study and expect to initiate dosing in the first quarter of 2024,
with topline data expected in the second half of 2024.
- Announced preliminary results from the open-label extension
portion of the Phase 2b/3 PRISM trial
in prurigo nodularis in which 151 subjects completed the open label
extension portion of the trial. The safety data over 52 weeks of
treatment demonstrated that Haduvio was well-tolerated and
consistent with the 14-week blinded safety data. In addition, there
was a continued reduction in Worst Itch Numerical Rating Scale, or
WI-NRS, scores observed among participants who remained in the
study through 52 weeks of treatment.
- Ended the third quarter of 2023 with $88.9 million in cash, cash equivalents and
marketable securities.
Third Quarter 2023 Financial Highlights
Research and development (R&D) expenses: R&D
expenses for the third quarter of 2023 increased to $6.3 million from $5.8
million in the same period in 2022. The increase was
primarily due to higher startup costs and consultant services
associated with our chronic cough programs as well as an increase
in personnel-related expenses. These increases were partially
offset by a decline in clinical development expenses related to our
completed Phase 2b/3 PRISM trial and
our Phase 2 CANAL trial as well as decreased purchases of clinical
trial supplies, among other factors.
General and administrative (G&A) expenses: G&A
expenses were $2.7 million in the
third quarter of 2023 compared to $2.6
million in the same period in 2022.
Other income, net: Other income, net was $1.3 million in the third quarter of 2023
compared to other income, net of $0.1
million in the same period in 2022. The change was primarily
due to an increase in interest income and reduced interest expense
due to the payoff of the SVB Term Loan in May 2023.
Net loss: For the third quarter of 2023, the Company
reported a net loss of $7.7 million,
compared to a net loss of $8.3
million in the same period in 2022.
Conference Call/Webcast
To participate in today's live
conference call by phone, please dial (888) 317 6003 (domestic) or
(412) 317 6061 (international) and provide access code 5615817. A
live audio webcast will be accessible from the 'Investors &
News' section on the Company's website at
www.TreviTherapeutics.com. An archived replay of the webcast will
also be available for 30 days on the Company's website following
the event.
Upcoming Meetings
The Company plans to participate in
the following conference:
- Nov 14-15: Stifel 2023 Healthcare Conference –
New York, NY
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), refractory chronic cough (RCC), and
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 or Europe.
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, expectations regarding Trevi's uses and
sufficiency of capital, 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,
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.
Trevi Therapeutics,
Inc.
Selected Balance
Sheet Data
(unaudited)
(amounts in
thousands)
|
|
|
|
September 30,
2023
|
|
|
December 31,
2022
|
|
Cash and cash
equivalents
|
|
$
|
25,965
|
|
|
$
|
12,589
|
|
Marketable
securities
|
|
|
62,903
|
|
|
|
107,921
|
|
Working
capital
|
|
|
88,780
|
|
|
|
109,216
|
|
Total assets
|
|
|
95,896
|
|
|
|
123,015
|
|
Total debt
|
|
|
—
|
|
|
|
9,151
|
|
Stockholders'
equity
|
|
|
89,610
|
|
|
|
107,459
|
|
Trevi Therapeutics,
Inc.
Selected Statement
of Operations Data
(unaudited)
(amounts in
thousands, except per share amounts)
|
|
|
|
Three Months
Ended
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
6,323
|
|
|
$
|
5,769
|
|
|
$
|
17,165
|
|
|
$
|
15,517
|
|
General and
administrative
|
|
|
2,722
|
|
|
|
2,636
|
|
|
|
7,825
|
|
|
|
7,733
|
|
Total operating
expenses
|
|
|
9,045
|
|
|
|
8,405
|
|
|
|
24,990
|
|
|
|
23,250
|
|
Loss from
operations
|
|
|
(9,045)
|
|
|
|
(8,405)
|
|
|
|
(24,990)
|
|
|
|
(23,250)
|
|
Other income
(expense), net
|
|
|
1,334
|
|
|
|
132
|
|
|
|
3,696
|
|
|
|
(413)
|
|
Loss before income
taxes
|
|
|
(7,711)
|
|
|
|
(8,273)
|
|
|
|
(21,294)
|
|
|
|
(23,663)
|
|
Income tax
benefit
|
|
|
13
|
|
|
|
7
|
|
|
|
50
|
|
|
|
16
|
|
Net loss
|
|
$
|
(7,698)
|
|
|
$
|
(8,266)
|
|
|
$
|
(21,244)
|
|
|
$
|
(23,647)
|
|
Basic and diluted net
loss per
common share outstanding
|
|
$
|
(0.08)
|
|
|
$
|
(0.12)
|
|
|
$
|
(0.21)
|
|
|
$
|
(0.44)
|
|
Weighted average common
shares
used in net loss per share attributable
to common stockholders, basic and
diluted
|
|
|
99,325,540
|
|
|
|
68,898,810
|
|
|
|
98,880,882
|
|
|
|
53,221,949
|
|
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.