NEW HAVEN, Conn., May 13, 2021 /PRNewswire/ -- Trevi
Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of the investigational therapy Haduvio™
(nalbuphine ER) to treat serious neurologically mediated
conditions, today announced financial results for the quarter ended
March 31, 2021, as well as business
updates.
Fast Track Designation Granted by FDA for Moderate to Severe
Pruritus in Prurigo Nodularis (PN)
"We continue to make progress in our clinical development
programs for the treatment of chronic pruritus in patients with PN
and chronic cough in patients with Idiopathic Pulmonary Fibrosis
(IPF)," said Jennifer L. Good, President and CEO of Trevi
Therapeutics. "Our PRISM trial is over 70% enrolled and we expect
to complete enrollment in the second half of this year. We also
recently received FDA Fast Track designation for moderate to severe
pruritus in PN, evidencing the seriousness of this condition. In
addition, our CANAL trial has resumed screening subjects since the
COVID-19 shelter in place directive was lifted at the end of March
in the UK and we are very pleased to see screening activity resume.
We remain focused on completing enrollment in both trials and
planning for the next steps in clinical development," concluded Ms.
Good.
Key Business Updates
- Phase 2b/3 PRISM trial of
Haduvio for severe pruritus in patients with mild to severe prurigo
nodularis: The PRISM trial has enrolled approximately 255 out
of the planned 360 total subjects in the trial. We expect to
complete enrollment in the second half of 2021, with top-line data
to be reported approximately four months after enrollment is
complete.
The U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to
nalbuphine ER for the proposed indication of reduction of moderate
to severe pruritus in patients with prurigo nodularis. Fast Track
designation is intended to facilitate development and expedite
review of drugs to treat serious and life-threatening conditions so
that an approved product can reach the market
expeditiously.
- Phase 2 CANAL trial of Haduvio for chronic cough in patients
with idiopathic pulmonary fibrosis: Sites for our CANAL trial
have resumed screening since the UK's shelter in place order was
lifted at the end of March 2021. We
continue to work with the sites in the U.K. that have not yet
resumed screening to fully reopen the trial.
First Quarter 2021 Financial Highlights
Cash position: As of March 31,
2021, the Company had total cash and cash equivalents of
$41.6 million, compared to
$45.0 million as of December 31, 2020. The Company expects its
current cash position will fund operations into the second quarter
of 2022.
Research and development (R&D) expenses: R&D
expenses for the first quarter of 2021 were $5.6 million compared to $6.0 million in the same period in 2020. The
decrease was primarily due to a decrease in clinical development
expenses related to decreased purchases of clinical trial supplies
and decreased expenses reflecting the completion of our Phase
1b clinical trial in patients with
chronic liver disease in the first half of 2020. These
decreased clinical development expenses were partially offset by
increased costs associated with higher activity and enrollment in
the Company's ongoing Phase 2b/3
PRISM trial, an increase in personnel-related expenses and higher
consulting and professional fees.
General and administrative (G&A) expenses: G&A
expenses for the first quarter of 2021 were $2.5 million compared to $2.6 million in the same period in 2020. The
decrease was primarily due to a decrease in stock-based
compensation expense.
Net loss: For the first quarter of 2021, the Company
reported a net loss of $8.4 million,
compared to a net loss of $8.5
million in the same period in 2020.
Conference Call
As previously announced, the Company
will host a conference call and webcast today, Thursday, May 13, 2021 at 4:30 p.m. ET. To participate in the live
conference call by phone, please dial (888) 317-6003 (domestic) or
(412) 317-6061 (international) and provide access code 6116464. 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.
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 patients with
idiopathic pulmonary fibrosis (IPF). Trevi is also developing
Haduvio for the treatment of levodopa-induced dyskinesia (LID) in
patients with Parkinson's disease. 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
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.
Nalbuphine is not currently classified as a controlled substance by
the DEA in the United States and by regulatory
authorities in most of Europe. Trevi intends to
propose Haduvio as the trade name for nalbuphine ER. Haduvio is an
investigational therapy that has been granted Fast Track
designation by FDA for the proposed indication of reduction of
moderate to severe pruritus in patients 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 impact of
the COVID-19 pandemic on Trevi's clinical trials, business and
operations; the expected timing of enrollment and for reporting
top-line data from Trevi's Phase 2b/3
PRISM trial of Haduvio in patients with prurigo nodularis; 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; 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; uncertainties regarding Trevi's ability
to execute on its strategy; the risk that positive results from a
clinical trial may not necessarily be predictive of the results of
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; as well as
other risks and uncertainties set forth in the annual report on
Form 10-K for the year ended December 31, 2020 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,
2021
|
|
|
December 31,
2020
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
41,570
|
|
|
$
45,001
|
Working
capital
|
|
36,821
|
|
|
40,714
|
Total
assets
|
|
42,864
|
|
|
47,131
|
Total debt
|
|
14,099
|
|
|
13,954
|
Stockholders'
equity
|
|
23,685
|
|
|
27,282
|
|
|
|
|
|
|
Trevi
Therapeutics, Inc. Selected Statement of Operations
Data (unaudited) (amounts in thousands)
|
|
|
|
Three Months
Ended
March
31,
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research
and development
|
|
$
5,589
|
|
|
$
6,019
|
General
and administrative
|
|
2,500
|
|
|
2,620
|
Total operating expenses
|
|
8,089
|
|
|
8,639
|
Loss from
operations
|
|
(8,089)
|
|
|
(8,639)
|
Other (expense)
income, net
|
|
(297)
|
|
|
157
|
Loss before income
tax benefit
|
|
(8,386)
|
|
|
(8,482)
|
Income tax
benefit
|
|
15
|
|
|
9
|
Net loss
|
|
$
(8,371)
|
|
|
$
(8,473)
|
|
|
|
|
|
|
|
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.