Accelerated planning for next phase of
development of Haduvio for the treatment of chronic cough in IPF
based on results from statistically significant interim analysis of
Phase 2 CANAL Trial
Completed enrollment for Phase 2b/3 PRISM study in chronic pruritus in PN with
data expected Q2 2022
Completed $55
million private placement in April
2022, proceeds will be used to fund clinical development of
Haduvio for the treatment of chronic cough in IPF patients
Management to host conference call and webcast
today at 4:30 p.m. EDT
NEW
HAVEN, Conn., May 12, 2022
/PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a
clinical-stage biopharmaceutical company developing an
investigational therapy Haduvio™ (nalbuphine ER) for pruritus
in prurigo nodularis (PN) and chronic cough in idiopathic pulmonary
fibrosis (IPF), today announced financial results for the quarter
ended March 31, 2022, as well as provided business
updates.
Trevi's topline data expected for
Ph2b/3 PRISM study this quarter and full results for Ph2 CANAL
study in Q3
"We are delighted with the significant progress made this year
in achieving Trevi's clinical development goals and the advancement
of Haduvio," said Jennifer Good,
President and CEO of Trevi Therapeutics. "The interim analysis
results of the Phase 2 CANAL study allowed us to end enrollment
early in the trial and begin preparations to accelerate development
for this indication."
Ms. Good added, "Additionally, the successful closing of a
$55 million private placement on
April 11, 2022, allows us to fund the
next phase of development for Haduvio in chronic cough in IPF. We
look forward to our expected data readout for the Phase
2b/3 PRISM study this quarter and the
data readout from the full set of subjects for the Phase 2 CANAL
study in the third quarter of this year."
Key Business Updates
- Phase 2 CANAL trial of Haduvio for chronic cough in patients
with IPF
-
- Concluded enrollment early for its Phase 2 Cough And NALbuphine
(CANAL) trial for the treatment of chronic cough in IPF
patients
- Statistically significant efficacy results from the interim
analysis (N=26) were announced:
-
- The primary efficacy endpoint demonstrated a 77.3% reduction in
daytime cough frequency from baseline with the use of Haduvio
compared to a 25.7% reduction with placebo, demonstrating a 52%
placebo-adjusted reduction in the geometric mean percent change in
the daytime cough frequency (p<0.0001)
- Expect to report efficacy and safety data on the full set of
subjects in the third quarter of 2022
- Phase 2b/3 PRISM trial of
Haduvio for severe pruritus in patients with PN
-
- Completed enrollment in Phase 2b/3 PRISM trial in January 2022
- Expect to report top-line data in the second quarter of
2022
- $55 million private placement
completed in April
-
- Proceeds will fund ongoing clinical development of Haduvio as
well as for working capital and other general corporate
purposes
First Quarter 2022 Financial Highlights
Cash position: As of March 31, 2022, the Company had
total cash and cash equivalents of $29.1
million. The Company's gross proceeds from the April 2022 private placement were $55.0 million.
Research and development (R&D) expenses: R&D
expenses for the first quarter of 2022 were $4.6 million compared to $5.6 million in the same period in 2021. The
decrease was primarily due to decreased clinical trial subject
recruitment costs. Our consulting expenses and professional fees
declined as well due to a reduction in consulting work and the
non-recurrence of professional recruiting fees related to hirings
in the prior year period.
General and administrative (G&A) expenses: G&A
expenses for the first quarter of 2022 were $2.4 million compared to $2.5 million in the same period in 2021. The
decrease was primarily due to lower legal fees as a result of the
timing of certain intellectual property filings.
Net loss: For the first quarter of 2022, the Company
reported a net loss of $7.3 million,
compared to a net loss of $8.4
million in the same period in 2021.
Conference Call
To participate in the live conference
call by phone, please dial (888) 317 6003 (domestic) or (412) 317
6061 (international) and provide access code 5008663. 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 present at the
following upcoming conferences and events:
- May 23-26: H.C. Wainwright Global
Investment Conference
- June 13-16: BIO International
Convention
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on the development and commercialization of the
investigational therapy Haduvio to treat serious neurologically
mediated conditions. Trevi is conducting a
Phase 2b/3 clinical trial of Haduvio for the treatment of
chronic pruritus associated with prurigo nodularis (PN) and a Phase
2 trial for chronic cough in adults with idiopathic pulmonary
fibrosis (IPF). These conditions share a common pathophysiology
that is mediated through opioid receptors in the central and
peripheral nervous systems.
Founded in 2011, Trevi Therapeutics is headquartered
in New Haven, CT.
About Haduvio
Haduvio, an investigational therapy, is an oral extended-release
(ER) formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid
receptor agonist and µ-opioid receptor antagonist that has been
approved and marketed as an injectable for pain indications for
more than 20 years in the United States and Europe.
The ĸ- and µ-opioid receptors are known to be critical mediators of
itch, cough and certain movement disorders. Nalbuphine's mechanism
of action may also mitigate the risk of abuse associated with
µ-opioid agonists because it antagonizes, or blocks, µ-opioid
receptors. Parenteral nalbuphine is not currently scheduled as a
controlled substance by the DEA in the United States or
by regulatory authorities in most
of Europe. Trevi intends to propose Haduvio as the
trade name for nalbuphine ER. Nalbuphine ER has been granted Fast
Track designation by the FDA for the proposed indication of
reduction of moderate to severe pruritus in adults with prurigo
nodularis. Its safety and efficacy have not been evaluated by any
regulatory authority.
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 the expected
timing of reporting top-line data from Trevi's Phase 2b/3 PRISM trial of Haduvio in subjects with PN
and the expected timing of reporting top-line data from the full
set of subjects' data from Trevi's Phase 2 CANAL trial of Haduvio
in IPF subjects with chronic cough; Trevi's business plans and
objectives, including future plans or expectations for Trevi's
product candidates; 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, including with
respect to the timing of reporting top-line data from both Trevi's
Phase 2b/3 PRISM trial and Phase 2
CANAL trial; uncertainties regarding Trevi's ability to execute on
its strategy; the risk that positive interim or top-line results
from a clinical trial may not necessarily be predictive of the
results of the completed trial or other future or ongoing clinical
trials; potential regulatory developments in the United States and foreign countries;
uncertainties regarding fast track designation and the effect such
status could have on the regulatory review or approval process;
uncertainties inherent in estimating Trevi's cash runway, future
expenses and other financial results, including Trevi's ability to
continue as a going concern, comply with its obligations under its
loan facility and fund future operations; uncertainties regarding
the scope, timing and severity of the COVID-19 pandemic, the impact
of the COVID-19 pandemic on Trevi's clinical operations and actions
taken in response to the pandemic; as well as other risks and
uncertainties set forth in the quarterly report on Form 10-Q for
the quarter ended March 31, 2022
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)
|
|
|
|
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
Cash and cash
equivalents
|
|
$
|
29,113
|
|
|
$
|
36,830
|
|
Working
capital
|
|
|
16,972
|
|
|
|
25,233
|
|
Total assets
|
|
|
30,386
|
|
|
|
38,475
|
|
Total debt
|
|
|
14,056
|
|
|
|
14,485
|
|
Stockholders'
equity
|
|
|
10,463
|
|
|
|
17,075
|
|
Trevi Therapeutics,
Inc.
Selected Statement
of Operations Data
(unaudited)
(amounts in
thousands, except per share amounts)
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$
|
4,645
|
|
|
$
|
5,589
|
|
General
and administrative
|
|
|
2,380
|
|
|
|
2,500
|
|
Total operating
expenses
|
|
|
7,025
|
|
|
|
8,089
|
|
Loss from
operations
|
|
|
(7,025)
|
|
|
|
(8,089)
|
|
Other
expense, net
|
|
|
(309)
|
|
|
|
(297)
|
|
Loss before income
taxes
|
|
|
(7,334)
|
|
|
|
(8,386)
|
|
Income
tax benefit
|
|
|
5
|
|
|
|
15
|
|
Net loss
|
|
$
|
(7,329)
|
|
|
$
|
(8,371)
|
|
Basic and diluted net
loss per common share outstanding
|
|
$
|
(0.24)
|
|
|
$
|
(0.43)
|
|
Weighted average common
shares used in net
loss per
share attributable to common
stockholders, basic and diluted
|
|
|
30,805,804
|
|
|
|
19,417,038
|
|
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.