Reported positive results from the Phase
2b/3 PRISM trial of Haduvio™ in the
treatment of Prurigo Nodularis
Completed a $55
million private placement
Data from the full set of subjects in the
completed Phase 2 CANAL trial in chronic cough in idiopathic
pulmonary fibrosis (IPF) expected in the third quarter of
2022
Management to host a conference call and
webcast today at 4:30 p.m.
EDT
NEW
HAVEN, Conn., Aug. 11,
2022 /PRNewswire/ -- Trevi Therapeutics, Inc.
(Nasdaq: TRVI), a clinical-stage biopharmaceutical company
developing an investigational therapy Haduvio™ (oral
nalbuphine ER) for the treatment of prurigo nodularis and chronic
cough in adults with idiopathic pulmonary fibrosis (IPF), today
announced financial results for the quarter ended June 30,
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
"The positive trial results reported this quarter in the
treatment of prurigo nodularis not only further support the
continued development of Haduvio in another therapeutic indication
with a high unmet need, but also reaffirms the mechanism of action
and the importance of having both a peripheral and centrally active
therapy," said Jennifer Good,
President and CEO of Trevi Therapeutics. "As a next step in our
prurigo nodularis program, we plan to request an end of phase 2
meeting with the FDA. In our chronic cough in IPF program, we are
looking forward to providing topline efficacy and safety data on
the full set of subjects enrolled in the completed Phase 2 CANAL
study this quarter. We are actively preparing for the next trial in
chronic cough in IPF and are looking forward to discussing the
program and trial plan with the FDA at a meeting scheduled for this
quarter."
Key Business Updates
Phase 2b/3 PRISM trial of
Haduvio in the treatment of Prurigo Nodularis
As previously announced in the Phase 2b/3 PRISM trial, results comparing subjects
randomized to Haduvio (n=168) or placebo (n=176) achieved the
primary and two key secondary endpoints. In addition, the Company
has received the analysis on the final key secondary endpoint, the
PROMIS sleep scale, which also achieved that endpoint with
statistical significance at week 14. Below is a summary of the
primary and all key secondary endpoints:
- 25% of Haduvio subjects evaluated at week 14 met the primary
endpoint of a 4-point reduction in the Worst Itch Numerical Rating
Scale from baseline compared to 14% of placebo subjects
(p=0.0157).
- Haduvio subjects experienced significantly greater improvements
in ItchyQoL vs. placebo (p=0.0002) at week 14, which was
statistically significant across each of the three domains
(symptoms, functional limitations, and emotions). ItchyQoL is used
to measure how pruritus impacts a subject's quality of life.
- 55% of Haduvio subjects had at least a 1-category improvement
in the 5-point scale in their Prurigo Activity Score (PAS)
(pruriginous lesions with excoriations), vs. 38% on placebo
(p=0.006) as evaluated at week 14.
- Haduvio subjects experienced significantly greater improvements
in the PROMIS sleep disturbance short form 8a vs. placebo
(p=0.0002) at week 14. The first assessment of PROMIS was made at
week 6 of the trial and results at week 6 also demonstrated a
statistically significant improvement.
Private Placement
- Completed a $55 million private
placement in April 2022 to further
the clinical development of Haduvio.
Second Quarter 2022 Financial Highlights
Cash position: As of June 30, 2022, the Company had
total cash, cash equivalents and marketable securities of
$78.9 million.
Research and development (R&D) expenses: R&D
expenses for the second quarter of 2022 were $5.1 million compared to $6.5 million in the same period in 2021. The
decrease was primarily due to reduced purchases of clinical trial
supplies and clinical trial subject recruitment costs, a reduction
in our use of consulting services 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 were $2.7 million in the
second quarter of 2022 and the second quarter of 2021.
Net loss: For the second quarter of 2022, the Company
reported a net loss of $8.1 million,
compared to a net loss of $9.8
million in the same period in 2021. The decrease was
primarily due to the decrease in R&D expenses.
Conference Call
To participate in the live conference
call on Thursday, August 11, by
phone, please dial (888) 317-6003 (domestic) or (412) 317-6061
(international) and provide access code 9437525. 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:
- August 15-17: Stifel Biotech
Executive Summer Summit
- August 29: 6th Annual
IPF Summit
- September 12-14: H.C. Wainwright
24th Annual Global Investment Conference
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on the development and commercialization of the
investigational therapy Haduvio for the treatment of prurigo
nodularis and chronic cough in adults with idiopathic pulmonary
fibrosis. 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 treatment of itch 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 expected
timing of reporting top-line data from the full set of subjects'
data from Trevi's Phase 2 CANAL trial of Haduvio in chronic cough
in adults with IPF; Trevi's business plans and objectives,
including future plans or expectations for Haduvio; 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 the 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 June 30, 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)
|
|
|
|
June 30, 2022
|
|
|
December 31, 2021
|
|
Cash and cash
equivalents
|
|
$
|
24,698
|
|
|
$
|
36,830
|
|
Marketable
securities
|
|
|
54,157
|
|
|
|
—
|
|
Working
capital
|
|
|
64,452
|
|
|
|
25,233
|
|
Total assets
|
|
|
81,414
|
|
|
|
38,475
|
|
Total debt
|
|
|
12,428
|
|
|
|
14,485
|
|
Stockholders'
equity
|
|
|
60,515
|
|
|
|
17,075
|
|
Trevi Therapeutics,
Inc. Selected Statement of Operations Data
(unaudited) (amounts in thousands, except per share
amounts)
|
|
|
|
Three Months
Ended
June 30,
|
|
|
Six Months
Ended
June 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
5,103
|
|
|
$
|
6,498
|
|
|
$
|
9,748
|
|
|
$
|
12,087
|
|
General and
administrative
|
|
|
2,717
|
|
|
|
2,669
|
|
|
|
5,097
|
|
|
|
5,169
|
|
Total operating
expenses
|
|
|
7,820
|
|
|
|
9,167
|
|
|
|
14,845
|
|
|
|
17,256
|
|
Loss from
operations
|
|
|
(7,820)
|
|
|
|
(9,167)
|
|
|
|
(14,845)
|
|
|
|
(17,256)
|
|
Other expense,
net
|
|
|
(236)
|
|
|
|
(629)
|
|
|
|
(545)
|
|
|
|
(926)
|
|
Loss before income
taxes
|
|
|
(8,056)
|
|
|
|
(9,796)
|
|
|
|
(15,390)
|
|
|
|
(18,182)
|
|
Income tax
benefit
|
|
|
4
|
|
|
|
2
|
|
|
|
9
|
|
|
|
17
|
|
Net loss
|
|
$
|
(8,052)
|
|
|
$
|
(9,794)
|
|
|
$
|
(15,381)
|
|
|
$
|
(18,165)
|
|
Basic and diluted net
loss per common share
outstanding
|
|
$
|
(0.14)
|
|
|
$
|
(0.49)
|
|
|
$
|
(0.34)
|
|
|
$
|
(0.92)
|
|
Weighted average common
shares used in net
loss per
share attributable to common
stockholders, basic and diluted
|
|
|
59,542,628
|
|
|
|
20,123,461
|
|
|
|
45,253,599
|
|
|
|
19,772,201
|
|
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.